Hydrocodone bitartrate and acetaminophen tablet

Ingredients and appearance - Product information

Hydrocodone bitartrate and acetaminophen tablet- Hydrocodone bitartrate and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 65162-120
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydrocodone bitartrate ( UNII: NO70W886KK)( Hydrocodone - UNII: 6YKS4Y3WQ7 ) 10 mgin 1
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 500 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Crospovidone ( UNII: 68401960MK)
Povidones ( UNII: FZ989GH94E)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color BLUE (light blue) Imprint Code IP;120
Score 2 Shape CAPSULE
Size 15 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040813 USA

Labeler - Amneal Pharmaceuticals of New York, LLC( 123797875)

Establishment

Name ID/FEI Business Operations
Amneal Pharmaceuticals of New York, LLC 123797875 ANALYSIS( 65162-120), LABEL( 65162-120), MANUFACTURE( 65162-120), PACK( 65162-120), REPACK( 65162-120)