UBRELVY (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC 0023-6498-10
tradename
(ubrogepant) tablets
50 mg
Rx onlycontains 10 Tablets

PRINCIPAL DISPLAY PANEL
NDC 0023-6498-10
tradename
(ubrogepant) tablets
50 mg
Rx only
contains 10 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0023-6498-30
tradename
(ubrogepant) tablets
50 mg
Rx onlycontains 30 Tablets

PRINCIPAL DISPLAY PANEL
NDC 0023-6498-30
tradename
(ubrogepant) tablets
50 mg
Rx only
contains 30 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0023-6501-02
tradename
(ubrogepant) tablet
100 mg
Rx onlycontains 1 Tablet

PRINCIPAL DISPLAY PANEL
NDC 0023-6501-02
tradename
(ubrogepant) tablet
100 mg
Rx only
contains 1 Tablet
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0023-6501-10
tradename
(ubrogepant) tablets
100 mg
Rx onlycontains 10 Tablets

PRINCIPAL DISPLAY PANEL
NDC 0023-6501-10
tradename
(ubrogepant) tablets
100 mg
Rx only
contains 10 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0023-6501-30
tradename
(ubrogepant) tablets
100 mg
Rx onlycontains 30 Tablets

PRINCIPAL DISPLAY PANEL
NDC 0023-6501-30
tradename
(ubrogepant) tablets
100 mg
Rx only
contains 30 Tablets
(click image for full-size original)
UBRELVY ubrogepant tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-6498
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UBROGEPANT (UBROGEPANT) UBROGEPANT 50 mg
Inactive Ingredients
Ingredient Name Strength
TOCOPHERSOLAN
MANNITOL
MICROCRYSTALLINE CELLULOSE
SODIUM CHLORIDE
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code U;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-6498-06 6 PACKET in 1 BOX contains a PACKET
1 1 TABLET in 1 PACKET This package is contained within the BOX (0023-6498-06)
2 NDC:0023-6498-08 8 PACKET in 1 BOX contains a PACKET
2 1 TABLET in 1 PACKET This package is contained within the BOX (0023-6498-08)
3 NDC:0023-6498-10 10 PACKET in 1 BOX contains a PACKET
3 1 TABLET in 1 PACKET This package is contained within the BOX (0023-6498-10)
4 NDC:0023-6498-12 12 PACKET in 1 BOX contains a PACKET
4 1 TABLET in 1 PACKET This package is contained within the BOX (0023-6498-12)
5 NDC:0023-6498-30 30 PACKET in 1 BOX contains a PACKET
5 1 TABLET in 1 PACKET This package is contained within the BOX (0023-6498-30)
6 NDC:0023-6498-16 16 PACKET in 1 BOX contains a PACKET
6 1 TABLET in 1 PACKET This package is contained within the BOX (0023-6498-16)
7 NDC:0023-6498-02 1 TABLET in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211765 12/23/2019
UBRELVY ubrogepant tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-6501
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UBROGEPANT (UBROGEPANT) UBROGEPANT 100 mg
Inactive Ingredients
Ingredient Name Strength
TOCOPHERSOLAN
MANNITOL
MICROCRYSTALLINE CELLULOSE
SODIUM CHLORIDE
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code U;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-6501-06 6 PACKET in 1 BOX contains a PACKET
1 1 TABLET in 1 PACKET This package is contained within the BOX (0023-6501-06)
2 NDC:0023-6501-08 8 PACKET in 1 BOX contains a PACKET
2 1 TABLET in 1 PACKET This package is contained within the BOX (0023-6501-08)
3 NDC:0023-6501-10 10 PACKET in 1 BOX contains a PACKET
3 1 TABLET in 1 PACKET This package is contained within the BOX (0023-6501-10)
4 NDC:0023-6501-12 12 PACKET in 1 BOX contains a PACKET
4 1 TABLET in 1 PACKET This package is contained within the BOX (0023-6501-12)
5 NDC:0023-6501-30 30 PACKET in 1 BOX contains a PACKET
5 1 TABLET in 1 PACKET This package is contained within the BOX (0023-6501-30)
6 NDC:0023-6501-16 16 PACKET in 1 BOX contains a PACKET
6 1 TABLET in 1 PACKET This package is contained within the BOX (0023-6501-16)
7 NDC:0023-6501-02 1 TABLET in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211765 12/23/2019
Labeler — Allergan, Inc. (144796497)

Revised: 06/2020 Allergan, Inc.

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