Oxycodone and acetaminophen tablet

Ingredients and appearance - Product information

Oxycodone and acetaminophen tablet- Oxycodone hydrochloride and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0603-4978
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Oxycodone hydrochloride ( UNII: C1ENJ2TE6C)( Oxycodone - UNII: CD35PMG570 ) 2.5 mgin 1
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Starch, corn ( UNII: O8232NY3SJ)
Croscarmellose sodium ( UNII: M28OL1HH48)
Crospovidone ( UNII: 2S7830E561)
D&c red no. 27 ( UNII: 2LRS185U6K)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Povidone ( UNII: FZ989GH94E)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color PINK Imprint Code 4825;V
Score 1 Shape OVAL
Size 15 mm


# Item Code Package Description Marketing Start Date
1 NDC: 0603-4978-21 100 in 1 BOTTLE, PLASTIC 2013/07/11

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA090733 USA 2013/07/11

Labeler - Par Pharmaceutical( 011103059)