Naltrexone hydrochloride tablet, film coated

Ingredients and appearance - Product information

Naltrexone hydrochloride tablet, film coated- Naltrexone hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 43063-591
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Naltrexone hydrochloride ( UNII: Z6375YW9SF)( Naltrexone - UNII: 5S6W795CQM ) 50 mgin 1

Inactive Ingredients

Ingredient Name Code
Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferric oxide yellow ( UNII: EX438O2MRT)
Ferric oxide red ( UNII: 1K09F3G675)

Product Characteristics

Color yellow Imprint Code 5;0;1170
Score 2 Shape OVAL
Size 13 mm


# Item Code Package Description Marketing Start Date
1 NDC: 43063-591-15 15 in 1 BOTTLE, PLASTIC 2015/08/17

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076264 USA 2015/08/17

Labeler - PD-Rx Pharmaceuticals, Inc.( 156893695)


Name ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack( 43063-591)