Meclizine Hydrochloride
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval:
Approved
Approval ID
467e464b-bbaf-4053-9136-39e47a92fa05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 21, 2020
Manufacturers
FDA
Epic Pharma LLC
DUNS: 827915443
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-012
Application NumberANDA200294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meclizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2020
FDA Product Classification
INGREDIENTS (6)
MECLIZINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Meclizine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-014
Application NumberANDA200294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meclizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2020
FDA Product Classification
INGREDIENTS (5)
MECLIZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT