MECLIZINE HYDROCHLORIDE
Meclizine hydrochloride tablets, USPRx Only
Approved
Approval ID
478bac81-1b81-4c8e-b894-019c5a039b6d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2019
Manufacturers
FDA
DOH CENTRAL PHARMACY
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Meclizine Hydrocloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-1116
Application NumberANDA040659
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meclizine Hydrocloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2019
FDA Product Classification
INGREDIENTS (8)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MECLIZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT