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: 0904-6420
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydrocodone bitartrate ( UNII: NO70W886KK)( Hydrocodone - UNII: 6YKS4Y3WQ7 ) 7.5 mgin 1
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1

Inactive Ingredients

Ingredient Name Code
Microcrystalline cellulose ( UNII: OP1R32D61U)
Croscarmellose sodium ( UNII: M28OL1HH48)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color WHITE Size 14 mm
Shape OVAL (capsule-shaped) Score 2
Imprint Code WATSON;3203

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040148 USA

Hydrocodone bitartrate and acetaminophen tablet- Hydrocodone bitartrate and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0904-6421
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 ) 325 mgin 1

Inactive Ingredients

Ingredient Name Code
Microcrystalline cellulose ( UNII: OP1R32D61U)
Croscarmellose sodium ( UNII: M28OL1HH48)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color WHITE Size 14 mm
Shape OVAL (capsule-shaped) Score 2
Imprint Code WATSON;853

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040148 USA

Labeler - Major Pharmaceuticals( 191427277)

Package/label display panel

Hydrocodone Bitartrate and Acetaminophen Tablets, USP

CII

7.5mg/ 325mg

100 Tablets

Package/label display panel

Hydrocodone Bitartrate and Acetaminophen Tablets, USP

CII

10mg/ 325mg

100 Tablets