Promethazine hydrochloride tablet

Ingredients and appearance - Product information

Promethazine hydrochloride tablet- Promethazine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 33261-865
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Promethazine hydrochloride ( UNII: R61ZEH7I1I)( Promethazine - UNII: FF28EJQ494 ) 12.5 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Methylcellulose (100 cps) ( UNII: 4GFU244C4J)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)

Product Characteristics

Color ORANGE Imprint Code K;2
Score 2 Shape ROUND
Size 8 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 33261-865-30 30 in 1 BOTTLE, PLASTIC 2012/07/17

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040712 USA 2012/07/17

Promethazine hydrochloride tablet- Promethazine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 33261-131
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Promethazine hydrochloride ( UNII: R61ZEH7I1I)( Promethazine - UNII: FF28EJQ494 ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Methylcellulose (100 cps) ( UNII: 4GFU244C4J)

Product Characteristics

Color WHITE Imprint Code K;3
Score 4 Shape ROUND
Size 8 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 33261-131-10 10 in 1 BOTTLE, PLASTIC 2012/07/17
2 NDC: 33261-131-12 12 in 1 BOTTLE, PLASTIC 2012/07/17
3 NDC: 33261-131-15 15 in 1 BOTTLE, PLASTIC 2012/07/17
4 NDC: 33261-131-16 16 in 1 BOTTLE, PLASTIC 2012/07/17
5 NDC: 33261-131-20 20 in 1 BOTTLE, PLASTIC 2012/07/17
6 NDC: 33261-131-30 30 in 1 BOTTLE, PLASTIC 2012/07/17
7 NDC: 33261-131-40 40 in 1 BOTTLE, PLASTIC 2012/07/17
8 NDC: 33261-131-60 60 in 1 BOTTLE, PLASTIC 2012/07/17
9 NDC: 33261-131-90 90 in 1 BOTTLE, PLASTIC 2012/07/17

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040712 USA 2012/07/17

Labeler - Aidarex Pharmaceuticals LLC( 801503249)