NDC Code(s) : 0093-0819-01, 0093-0819-55, 0093-5173-01, 0093-5173-55
Packager : Teva Pharmaceuticals USA Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Nifedipinenifedipine TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0819
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
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(UNII: S38J6RZN16)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(UNII: 5KY68S2577)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color RED (reddish brown) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code B;30
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-0819-01100 in 1 BOTTLE Type 0: Not a Combination Product02/09/2001
2NDC:0093-0819-55300 in 1 BOTTLE Type 0: Not a Combination Product02/09/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075289 02/09/2001
Nifedipinenifedipine TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5173
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
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(UNII: S38J6RZN16)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(UNII: 5KY68S2577)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color RED (reddish brown) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code B;60
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-5173-01100 in 1 BOTTLE Type 0: Not a Combination Product12/11/2000
2NDC:0093-5173-55300 in 1 BOTTLE Type 0: Not a Combination Product12/11/2000
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075289 12/11/2000

PRINCIPAL DISPLAY PANEL

NDC 0093-0819-01

NIFEdipine
Extended-release
Tablets, USP
30 mg

Rx only

100 TABLETS

TEVA

carton1.jpg

PRINCIPAL DISPLAY PANEL

NDC 0093-5173-01

NIFEdipine
Extended-release
Tablets, USP
60 mg

Rx only

100 TABLETS

TEVA

carton2.jpg