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 useRx OnlyInitial U.S. Approval: 1957
Approved
Approval ID
6a8cbc12-0725-4462-bb71-0b18cefc19e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2023
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
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 Code71205-416
Application NumberANDA040659
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meclizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (8)
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Meclizine HydrochlorideActive
Quantity: 12.5 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Fd&c Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT