MedPath

Methazolamide

Methazolamide Tablets, USP 25 mg and 50 mg

Approved
Approval ID

375da1ab-d84d-4a2f-aded-3fe422972403

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 23, 2023

Manufacturers
FDA

TAGI Pharma, Inc.

DUNS: 963322560

Products 2

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

Methazolamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51224-024
Application NumberANDA215615
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methazolamide
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2023
FDA Product Classification

INGREDIENTS (6)

MethazolamideActive
Quantity: 25 mg in 1 1
Code: W733B0S9SD
Classification: ACTIB
Dibasic Calcium Phosphate DihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT

Methazolamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51224-124
Application NumberANDA215615
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methazolamide
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2023
FDA Product Classification

INGREDIENTS (6)

Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Dibasic Calcium Phosphate DihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
MethazolamideActive
Quantity: 50 mg in 1 1
Code: W733B0S9SD
Classification: ACTIB
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/23/2023

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

NDC 51224-124-50

Methazolamide
Tablets, USP

50 mg

Rx Only

tagi PHARMA
That's A Good Idea

100 tablets

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 3/23/2023

HOW SUPPLIED

Methazolamide Tablets USP, 25 mg are white to off white, uncoated, round, biconvex tablets debossed with '25' on one side and 'ZEN' on other side and are supplied in bottles of 100, NDC 51224-024-50.

Methazolamide Tablets USP, 50 mg are white to off white, uncoated, round, biconvex tablets debossed with '5 and 0' on either side of the break line one side and 'ZEN' on other side and are supplied in bottles of 100, NDC 51224-124-50.

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Methazolamide - FDA Drug Approval Details