UPTRAVI (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 200 mcg Tablet Bottle Carton

NDC 66215-602-06

Uptravi®
(selexipag)
tablets

200 mcg

Rx only

60 film-coated tablets

janssen

PRINCIPAL DISPLAY PANEL -- 200 mcg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 400 mcg Tablet Bottle Carton

NDC 66215-604-06

Uptravi®
(selexipag)
tablets

400 mcg

Rx only

60 film-coated tablets

janssen

PRINCIPAL DISPLAY PANEL -- 400 mcg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 600 mcg Tablet Bottle Carton

NDC 66215-606-06

Uptravi®
(selexipag)
tablets

600 mcg

Rx only

60 film-coated tablets

janssen

PRINCIPAL DISPLAY PANEL -- 600 mcg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 800 mcg Tablet Bottle Carton

NDC 66215-608-06

Uptravi®
(selexipag)
tablets

800 mcg

Rx only

60 film-coated tablets

janssen

PRINCIPAL DISPLAY PANEL -- 800 mcg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1000 mcg Tablet Bottle Carton

NDC 66215-610-06

Uptravi®
(selexipag)
tablets

1000 mcg

Rx only

60 film-coated tablets

janssen

PRINCIPAL DISPLAY PANEL -- 1000 mcg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1200 mcg Tablet Bottle Carton

NDC 66215-612-06

Uptravi®
(selexipag)
tablets

1200 mcg

Rx only

60 film-coated tablets

janssen

PRINCIPAL DISPLAY PANEL -- 1200 mcg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1400 mcg Tablet Bottle Carton

NDC 66215-614-06

Uptravi®
(selexipag)
tablets

1400 mcg

Rx only

60 film-coated tablets

janssen

PRINCIPAL DISPLAY PANEL -- 1400 mcg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1600 mcg Tablet Bottle Carton

NDC 66215-616-06

Uptravi®
(selexipag)
tablets

1600 mcg

Rx only

60 film-coated tablets

janssen

PRINCIPAL DISPLAY PANEL -- 1600 mcg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Kit Carton

NDC 66215-628-20

TITRATION PACK

Uptravi®
(selexipag)
tablets

200 mcg

Rx only

140 film-coated
tablets

Uptravi®
(selexipag)
tablets

800 mcg

Rx only

60 film-coated tablets

janssen

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1,800 mcg Vial Carton

NDC 66215-718-01

Uptravi®
(selexipag)
for injection

1,800 mcg/vial

FOR INTRAVENOUS INFUSION ONLY
Reconstitute and Dilute Prior to Use.

Single-dose vial. Discard unused portion.

Rx only
Sterile

One Vial

OPENHERE

PRINCIPAL DISPLAY PANEL -- 1,800 mcg Vial Carton
(click image for full-size original)
UPTRAVI selexipag tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66215-602
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEXIPAG (SELEXIPAG) SELEXIPAG 200 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1200000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
CARNAUBA WAX
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66215-602-06 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (66215-602-06)
2 NDC:66215-602-14 1 BOTTLE in 1 CARTON contains a BOTTLE
2 140 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (66215-602-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207947 12/21/2015
UPTRAVI selexipag tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66215-604
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEXIPAG (SELEXIPAG) SELEXIPAG 400 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1200000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERRIC OXIDE RED
CARNAUBA WAX
Product Characteristics
Color RED (red) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66215-604-06 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (66215-604-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207947 12/21/2015
UPTRAVI selexipag tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66215-606
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEXIPAG (SELEXIPAG) SELEXIPAG 600 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1200000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
CARNAUBA WAX
Product Characteristics
Color PURPLE (light violet) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66215-606-06 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (66215-606-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207947 12/21/2015
UPTRAVI selexipag tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66215-608
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEXIPAG (SELEXIPAG) SELEXIPAG 800 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1200000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
CARNAUBA WAX
Product Characteristics
Color GREEN (green) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66215-608-06 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (66215-608-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207947 12/21/2015
UPTRAVI selexipag tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66215-610
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEXIPAG (SELEXIPAG) SELEXIPAG 1000 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1200000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
CARNAUBA WAX
Product Characteristics
Color ORANGE (orange) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66215-610-06 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (66215-610-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207947 12/21/2015
UPTRAVI selexipag tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66215-612
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEXIPAG (SELEXIPAG) SELEXIPAG 1200 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1200000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
CARNAUBA WAX
Product Characteristics
Color PURPLE (dark violet) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66215-612-06 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (66215-612-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207947 12/21/2015
UPTRAVI selexipag tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66215-614
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEXIPAG (SELEXIPAG) SELEXIPAG 1400 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1200000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
CARNAUBA WAX
Product Characteristics
Color YELLOW (dark yellow) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66215-614-06 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (66215-614-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207947 12/21/2015
UPTRAVI selexipag tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66215-616
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEXIPAG (SELEXIPAG) SELEXIPAG 1600 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1200000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
CARNAUBA WAX
Product Characteristics
Color BROWN (brown) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66215-616-06 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (66215-616-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207947 12/21/2015
UPTRAVI TITRATION PACK selexipag kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66215-628
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66215-628-20 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 140
Part 2 1 BOTTLE 60
Part 1 of 2
UPTRAVI selexipag tablet, coated
Product Information
Item Code (Source) NDC:66215-602
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEXIPAG (SELEXIPAG) SELEXIPAG 200 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1200000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
CARNAUBA WAX
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 140 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207947 12/21/2015
Part 2 of 2
UPTRAVI selexipag tablet, coated
Product Information
Item Code (Source) NDC:66215-608
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEXIPAG (SELEXIPAG) SELEXIPAG 800 ug
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1200000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
CARNAUBA WAX
Product Characteristics
Color GREEN (green) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207947 12/21/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207947 12/21/2015
UPTRAVI selexipag injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66215-718
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEXIPAG (SELEXIPAG) SELEXIPAG 1800 ug in 10 mL
Inactive Ingredients
Ingredient Name Strength
glycine
phosphoric acid
polysorbate 20
sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66215-718-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (66215-718-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214275 07/29/2021
Labeler — Actelion Pharmaceuticals US, Inc. (002641228)
Establishment
Name Address ID/FEI Operations
Excella GmbH 329809800 ANALYSIS (66215-602), ANALYSIS (66215-604), ANALYSIS (66215-606), ANALYSIS (66215-608), ANALYSIS (66215-610), ANALYSIS (66215-612), ANALYSIS (66215-614), ANALYSIS (66215-616), ANALYSIS (66215-628), LABEL (66215-602), LABEL (66215-604), LABEL (66215-606), LABEL (66215-608), LABEL (66215-610), LABEL (66215-612), LABEL (66215-614), LABEL (66215-616), LABEL (66215-628), MANUFACTURE (66215-602), MANUFACTURE (66215-604), MANUFACTURE (66215-606), MANUFACTURE (66215-608), MANUFACTURE (66215-610), MANUFACTURE (66215-612), MANUFACTURE (66215-614), MANUFACTURE (66215-616), MANUFACTURE (66215-628), PACK (66215-602), PACK (66215-604), PACK (66215-606), PACK (66215-608), PACK (66215-610), PACK (66215-612), PACK (66215-614), PACK (66215-616), PACK (66215-628)
Establishment
Name Address ID/FEI Operations
Almac Sciences Limited 232665666 API MANUFACTURE (66215-602), API MANUFACTURE (66215-604), API MANUFACTURE (66215-606), API MANUFACTURE (66215-608), API MANUFACTURE (66215-610), API MANUFACTURE (66215-612), API MANUFACTURE (66215-614), API MANUFACTURE (66215-616), API MANUFACTURE (66215-628), API MANUFACTURE (66215-718), ANALYSIS (66215-602), ANALYSIS (66215-604), ANALYSIS (66215-606), ANALYSIS (66215-608), ANALYSIS (66215-610), ANALYSIS (66215-612), ANALYSIS (66215-614), ANALYSIS (66215-616), ANALYSIS (66215-628), ANALYSIS (66215-718)
Establishment
Name Address ID/FEI Operations
Butterworth Laboratories Ltd 225081538 ANALYSIS (66215-602), ANALYSIS (66215-604), ANALYSIS (66215-606), ANALYSIS (66215-608), ANALYSIS (66215-610), ANALYSIS (66215-612), ANALYSIS (66215-614), ANALYSIS (66215-616), ANALYSIS (66215-628)
Establishment
Name Address ID/FEI Operations
Almac Pharma Services Limited 233170864 ANALYSIS (66215-602), ANALYSIS (66215-604), ANALYSIS (66215-606), ANALYSIS (66215-608), ANALYSIS (66215-610), ANALYSIS (66215-612), ANALYSIS (66215-614), ANALYSIS (66215-616), ANALYSIS (66215-628), ANALYSIS (66215-718)
Establishment
Name Address ID/FEI Operations
SGS Institut Fresenius GmbH 317219699 ANALYSIS (66215-602), ANALYSIS (66215-604), ANALYSIS (66215-606), ANALYSIS (66215-608), ANALYSIS (66215-610), ANALYSIS (66215-612), ANALYSIS (66215-614), ANALYSIS (66215-616), ANALYSIS (66215-628)
Establishment
Name Address ID/FEI Operations
SGS Institut Fresenius GmbH 341259550 ANALYSIS (66215-602), ANALYSIS (66215-604), ANALYSIS (66215-606), ANALYSIS (66215-608), ANALYSIS (66215-610), ANALYSIS (66215-612), ANALYSIS (66215-614), ANALYSIS (66215-616), ANALYSIS (66215-628)
Establishment
Name Address ID/FEI Operations
AMATSIGROUP 265402977 MANUFACTURE (66215-718)
Establishment
Name Address ID/FEI Operations
Wickham Micro Limited 228216353 ANALYSIS (66215-718)
Establishment
Name Address ID/FEI Operations
Eurofins Amatsi Analytics 270324185 ANALYSIS (66215-718)
Establishment
Name Address ID/FEI Operations
Confarma France 492738125 ANALYSIS (66215-718)
Establishment
Name Address ID/FEI Operations
Konapharma AG 482314432 MANUFACTURE (66215-718)

Revised: 07/2022 Actelion Pharmaceuticals US, Inc.

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