acetazolamide

Generic: acetazolamide

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetazolamide
Generic Name acetazolamide
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

acetazolamide sodium 500 mg/5mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-661
Product ID 68083-661_de1a5d68-b82d-4a84-9362-f7edd73f377a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219775
Listing Expiration 2026-12-31
Marketing Start 2025-06-17

Pharmacologic Class

Classes
carbonic anhydrase inhibitor [epc] carbonic anhydrase inhibitors [moa] sulfonamides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083661
Hyphenated Format 68083-661

Supplemental Identifiers

RxCUI
307702
UPC
0368083661014
UNII
429ZT169UH

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name acetazolamide (source: ndc)
Generic Name acetazolamide (source: ndc)
Application Number ANDA219775 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-661-01) / 5 mL in 1 VIAL
source: ndc

Packages (1)

68083-661-01 1 VIAL in 1 CARTON (68083-661-01) / 5 mL in 1 VIAL

Ingredients (1)

acetazolamide sodium (500 mg/5mL)

Linked Drug Pages (1)

Acetazolamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "de1a5d68-b82d-4a84-9362-f7edd73f377a", "openfda": {"upc": ["0368083661014"], "unii": ["429ZT169UH"], "rxcui": ["307702"], "spl_set_id": ["2b9fb0dd-e42e-4f9b-bf24-98b268d877e5"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-661-01)  / 5 mL in 1 VIAL", "package_ndc": "68083-661-01", "marketing_start_date": "20250617"}], "brand_name": "Acetazolamide", "product_id": "68083-661_de1a5d68-b82d-4a84-9362-f7edd73f377a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "Sulfonamides [CS]"], "product_ndc": "68083-661", "generic_name": "Acetazolamide", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetazolamide", "active_ingredients": [{"name": "ACETAZOLAMIDE SODIUM", "strength": "500 mg/5mL"}], "application_number": "ANDA219775", "marketing_category": "ANDA", "marketing_start_date": "20250617", "listing_expiration_date": "20261231"}