MedPath

Acetazolamide

Acetazolamide Tablets USP

Approved
Approval ID

923031ec-8142-4570-b3a6-210441d97105

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 18, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

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

Acetazolamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63629-1195
Application NumberANDA214282
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetazolamide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2023
FDA Product Classification

INGREDIENTS (8)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETAZOLAMIDEActive
Quantity: 250 mg in 1 1
Code: O3FX965V0I
Classification: ACTIB

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Acetazolamide - FDA Drug Approval Details