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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
Effective Date
August 15, 2022
Labeling Type
Human Prescription Drug Label
Meclizine(12.5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Quality Care Products, LLC

Quality Care Products, LLC

831276758

Products1

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
55700-919
Application Number
NDA010721
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
September 22, 2021
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MeclizineActive
Code: HDP7W44CIOClass: ACTIBQuantity: 12.5 mg in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
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