Meclizine Hydrochloride
Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
Approved
Approval ID
46f1e0ac-d67d-4419-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2017
Manufacturers
FDA
Apotheca Inc.
DUNS: 051457844
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 Code12634-424
Application NumberANDA200294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meclizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2017
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MECLIZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB