Meclizine Hydrochloride
These highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 1957
Approved
Approval ID
4db44f59-97b4-4a8c-bdbb-d088c0fc4451
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2023
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Meclizine Hydrochloride
PRODUCT DETAILS
NDC Product Code62559-842
Application NumberANDA084657
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 31, 2021
Generic NameMeclizine Hydrochloride
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MECLIZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Meclizine Hydrochloride
PRODUCT DETAILS
NDC Product Code62559-841
Application NumberANDA084657
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 31, 2021
Generic NameMeclizine Hydrochloride
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MECLIZINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT