Adempas (Page 8 of 8)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 50419-250-01
Rx only
Adempas 0.5 mg
(riociguat) tablets
each tablet contains 0.5 mg of riociguat

Note to Dispencer: Provide a copy of the Adempas Medication Guide included in this carton to each patient and at each refill.

– 90 tablets- for oral administration

.5 carton
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 50419-251-01
Rx only
Adempas 1 mg
(riociguat) tablets
each tablet contains 1 mg of riociguat

Note to Dispencer: Provide a copy of the Adempas Medication Guide included in this cartonto each patient and at each refill.

– 90 tablets- for oral administration

1 Carton
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 50419-252-01
Rx only
Adempas 1.5 mg
(riociguat) tablets
each tablet contains 1.5 mg of riociguat

Note to Dispencer: Provide a copy of the Adempas Medication Guide included in this cartonto each patient and at each refill.

– 90 tablets- for oral administration

1.5 carton
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 50419-253-01
Rx only
Adempas 2 mg
(riociguat) tablets
each tablet contains 2 mg of riociguat

Note to Dispencer: Provide a copy of the Adempas Medication Guide included in this cartonto each patient and at each refill.

– 90 tablets- for oral administration

2 Carton
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 50419-254-01
Rx only
Adempas 2.5 mg
(riociguat) tablets
each tablet contains 2.5 mg of riociguat

Note to Dispencer: Provide a copy of the Adempas Medication Guide included in this cartonto each patient and at each refill.

– 90 tablets- for oral administration

2.5 carton
(click image for full-size original)
ADEMPAS riociguat tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-250
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIOCIGUAT (RIOCIGUAT) RIOCIGUAT .5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
PROPYLENE GLYCOL
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code 5R;Bayer
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-250-01 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50419-250-03 2 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
2 21 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the PACKAGE (50419-250-03)
3 NDC:50419-250-91 9 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204819 10/08/2013
ADEMPAS riociguat tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-251
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIOCIGUAT (RIOCIGUAT) RIOCIGUAT 1 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
PROPYLENE GLYCOL
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (pale) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code 1R;Bayer
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-251-01 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50419-251-03 2 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
2 21 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the PACKAGE (50419-251-03)
3 NDC:50419-251-91 9 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204819 10/08/2013
ADEMPAS riociguat tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-252
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIOCIGUAT (RIOCIGUAT) RIOCIGUAT 1.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
PROPYLENE GLYCOL
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (orange) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code 15R;Bayer
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-252-01 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50419-252-03 2 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
2 21 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the PACKAGE (50419-252-03)
3 NDC:50419-252-91 9 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204819 10/08/2013
ADEMPAS riociguat tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-253
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIOCIGUAT (RIOCIGUAT) RIOCIGUAT 2 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
PROPYLENE GLYCOL
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE (pale) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code 2R;Bayer
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-253-01 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50419-253-03 2 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
2 21 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the PACKAGE (50419-253-03)
3 NDC:50419-253-91 9 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204819 10/08/2013
ADEMPAS riociguat tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-254
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIOCIGUAT (RIOCIGUAT) RIOCIGUAT 2.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
PROPYLENE GLYCOL
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
TITANIUM DIOXIDE
Product Characteristics
Color RED (orange) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code 25R;Bayer
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-254-01 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50419-254-03 2 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
2 21 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the PACKAGE (50419-254-03)
3 NDC:50419-254-91 9 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204819 10/08/2013
Labeler — Bayer HealthCare Pharmaceuticals Inc. (005436809)
Establishment
Name Address ID/FEI Operations
Sharp Corporation 143696495 PACK (50419-250), PACK (50419-251), PACK (50419-252), PACK (50419-253), PACK (50419-254), LABEL (50419-250), LABEL (50419-251), LABEL (50419-252), LABEL (50419-253), LABEL (50419-254)
Establishment
Name Address ID/FEI Operations
Bayer AG 314947622 ANALYSIS (50419-250), ANALYSIS (50419-251), ANALYSIS (50419-252), ANALYSIS (50419-253), ANALYSIS (50419-254), MANUFACTURE (50419-250), MANUFACTURE (50419-251), MANUFACTURE (50419-252), MANUFACTURE (50419-253), MANUFACTURE (50419-254), LABEL (50419-250), LABEL (50419-251), LABEL (50419-252), LABEL (50419-253), LABEL (50419-254), PACK (50419-250), PACK (50419-251), PACK (50419-252), PACK (50419-253), PACK (50419-254)
Establishment
Name Address ID/FEI Operations
Bayer AG 323208116 API MANUFACTURE (50419-250), API MANUFACTURE (50419-251), API MANUFACTURE (50419-252), API MANUFACTURE (50419-253), API MANUFACTURE (50419-254), ANALYSIS (50419-250), ANALYSIS (50419-251), ANALYSIS (50419-252), ANALYSIS (50419-253), ANALYSIS (50419-254)
Establishment
Name Address ID/FEI Operations
Bayer AG 342872971 PARTICLE SIZE REDUCTION (50419-250), PARTICLE SIZE REDUCTION (50419-251), PARTICLE SIZE REDUCTION (50419-252), PARTICLE SIZE REDUCTION (50419-253), PARTICLE SIZE REDUCTION (50419-254), PACK (50419-250), PACK (50419-251), PACK (50419-252), PACK (50419-253), PACK (50419-254)

Revised: 01/2023 Bayer HealthCare Pharmaceuticals Inc.

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