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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

Proficient Rx LP

DUNS: 079196022

Effective Date

January 1, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

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.

Proficient Rx LP

Labeler

Proficient Rx LP

DUNS Number

079196022

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

71205-416

Application Number

ANDA040659

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 1, 2023

Ingredients

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

MeclizineActive

Code: HDP7W44CIOClass: ACTIBQuantity: 12.5 mg in 1 1

Croscarmellose SodiumInactive

Code: M28OL1HH48Class: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

Fd&c Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

Aluminum OxideInactive

Code: LMI26O6933Class: IACT

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