NDC Code(s) : 52125-993-02
Packager : REMEDYREPACK 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:52125-993(NDC:0378-0480)
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
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL(UNII: 532B59J990)
Product Characteristics
Color pink Score no score
Shape ROUND (TABLET, FILM COATED, EXTENDED RELEASE) Size 9 mm
Flavor Imprint Code M;030
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-993-0230 in 1 BLISTER PACK Type 0: Not a Combination Product29/07/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090649 07/29/2014 07/31/2015

PRINCIPAL DISPLAY PANEL

DRUG: Nifedipine


GENERIC: nifedipine


DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE


ADMINSTRATION: ORAL


NDC: 52125-993-02


ACTIVE INGREDIENT(S):

  • NIFEDIPINE 30mg in 1


INACTIVE INGREDIENT(S):

  • CELLULOSE ACETATE
  • SODIUM CHLORIDE
  • TALC
  • FERRIC OXIDE YELLOW
  • PROPYLENE GLYCOL
  • TITANIUM DIOXIDE
  • FERROSOFERRIC OXIDE
  • FERRIC OXIDE RED
  • HYDROXYPROPYL CELLULOSE (TYPE H)
  • HYPROMELLOSES
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOLS
  • POLYVINYL ALCOHOL


COLOR: pink


SHAPE: ROUND


SCORE: No score


SIZE: 9 mm


IMPRINT: M;030


PACKAGING: 30 in 1 BLISTER PACK




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