Meclizine hydrochloride tablet

Ingredients and appearance - Product information

Meclizine hydrochloride tablet- Meclizine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68071-4372
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Meclizine hydrochloride ( UNII: HDP7W44CIO)( Meclizine - UNII: 3L5TQ84570 ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Talc ( UNII: 7SEV7J4R1U)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)

Product Characteristics

Color yellow (Light) Imprint Code AN;442
Score 1 Shape OVAL
Size 13 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 68071-4372-7 10 in 1 BOTTLE 2018/04/05
2 NDC: 68071-4372-1 12 in 1 BOTTLE 2018/04/05
3 NDC: 68071-4372-6 60 in 1 BOTTLE 2018/04/05

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA201451 USA 2018/04/05

Labeler - NuCare Pharmaceuticals,Inc.( 010632300)

Establishment

Name ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 repack( 68071-4372)