Meclizine Hydrochloride
Meclizine Hydrochloride Tablets, USP Rx Only
Approved
Approval ID
af5d0c9b-a997-8033-afca-3c04221f2e76
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2023
Manufacturers
FDA
AvPAK
DUNS: 832926666
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 Code50268-523
Application NumberANDA201451
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meclizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MECLIZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
Meclizine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-522
Application NumberANDA201451
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meclizine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MECLIZINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB