Nifedipine tablet, film coated, extended release

Ingredients and appearance - Product information

Nifedipine tablet, film coated, extended release- Nifedipine

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 69189-0443
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nifedipine ( UNII: I9ZF7L6G2L)( Nifedipine - UNII: I9ZF7L6G2L ) 90 mgin 1

Inactive Ingredients

Ingredient Name Code
Ferrosoferric oxide ( UNII: XM0M87F357)
Cellulose acetate ( UNII: 3J2P07GVB6)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Povidones ( UNII: FZ989GH94E)
Propylene glycol ( UNII: 6DC9Q167V3)
Ferric oxide red ( UNII: 1K09F3G675)
Sodium chloride ( UNII: 451W47IQ8X)
Titanium dioxide ( UNII: 15FIX9V2JP)
Triacetin ( UNII: XHX3C3X673)
Polysorbate 20 ( UNII: 7T1F30V5YH)
Polyethylene glycol 400 ( UNII: B697894SGQ)

Product Characteristics

Color pink Imprint Code KU;262
Score 1 Shape ROUND (Biconvex)
Size 12 mm


# Item Code Package Description Marketing Start Date
1 NDC: 69189-0443-1 1 DOSE PACK 2015/12/02

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077410 USA 2015/12/02

Labeler - Avera McKennan Hospital( 068647668)


Name ID/FEI Business Operations
Avera McKennan Hospital 068647668 relabel( 69189-0443), repack( 69189-0443)