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FDA Approval

Meclizine Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
AvPAK
DUNS: 832926666
Effective Date
October 26, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Meclizine(25 mg in 1 1)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Meclizine Hydrochloride

Product Details

NDC Product Code
50268-523
Application Number
ANDA201451
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 26, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
MeclizineActive
Code: HDP7W44CIOClass: ACTIBQuantity: 25 mg in 1 1

Meclizine Hydrochloride

Product Details

NDC Product Code
50268-522
Application Number
ANDA201451
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 26, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MeclizineActive
Code: HDP7W44CIOClass: ACTIBQuantity: 12.5 mg in 1 1
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