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 use Initial U.S. Approval: 1957
Approved
Approval ID
18fe5e13-5583-45ee-ab6e-32e9af426bd8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
QPharma Inc
DUNS: 030620888
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 Code42708-127
Application NumberANDA201451
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meclizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MECLIZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB