NDC Code(s) : 50419-701-10, 50419-701-05, 50419-702-05, 50419-702-10, 50419-703-05
Packager : Bayer HealthCare Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Adalat CCnifedipine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-701
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIFEDIPINE(UNII: I9ZF7L6G2L)
(NIFEDIPINE - UNII:I9ZF7L6G2L) 		NIFEDIPINE30 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (120000 MW)(UNII: UKE75GEA7F)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 15 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50419-701-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/04/1993
2NDC:50419-701-05100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/04/1993
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020198 04/21/1993 12/10/2017
Adalat CCnifedipine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-702
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIFEDIPINE(UNII: I9ZF7L6G2L)
(NIFEDIPINE - UNII:I9ZF7L6G2L) 		NIFEDIPINE60 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (120000 MW)(UNII: UKE75GEA7F)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK (SALMON) Score no score
Shape ROUND Size 15 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50419-702-05100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/04/1993
2NDC:50419-702-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/04/1993
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020198 04/21/1993 11/10/2017
Adalat CCnifedipine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-703
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIFEDIPINE(UNII: I9ZF7L6G2L)
(NIFEDIPINE - UNII:I9ZF7L6G2L) 		NIFEDIPINE90 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (120000 MW)(UNII: UKE75GEA7F)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 15 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50419-703-05100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/04/1993
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020198 04/21/1993 11/10/2017

PRINCIPAL DISPLAY PANEL

Adalat 30 mg 1000 Tablet Label

83396521 NDC 50419-701-10

ADALAT© CC

(nifedipine)

Extended Release Tablets

30 mg

1000 Tablets Rx Only

Rx Only

adalat 30 mg 1000 label

PRINCIPAL DISPLAY PANEL

Adalat 60 mg 1000 Tablet Label

83396610       NDC 50419-702-10

ADALAT© CC

(nifedipine)

Extended Release Tablets

60 mg

1000 Tablets Rx Only

Rx Only

Adalat 60 mg 1000 Tablets

PRINCIPAL DISPLAY PANEL

Adalat 90 mg 1000 Tablet Label

83396645      NDC 50419-703-05

ADALAT© CC

(nifedipine)

Extended Release Tablets

90 mg

100 Tablets Rx Only

Rx Only

Adalat 90 mg 100 Tablets