acetazolamide

Generic: acetazolamide sodium

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetazolamide
Generic Name acetazolamide sodium
Labeler mylan institutional llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

acetazolamide sodium 500 mg/5mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-853
Product ID 67457-853_300661cb-a5d8-4edc-a191-72284744e1eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200880
Listing Expiration 2026-12-31
Marketing Start 2018-09-13

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 67457853
Hyphenated Format 67457-853

Supplemental Identifiers

RxCUI
307702
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 sodium (source: ndc)
Application Number ANDA200880 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (67457-853-50) / 5 mL in 1 VIAL
source: ndc

Packages (1)

67457-853-50 1 VIAL in 1 CARTON (67457-853-50) / 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": "300661cb-a5d8-4edc-a191-72284744e1eb", "openfda": {"unii": ["429ZT169UH"], "rxcui": ["307702"], "spl_set_id": ["521838b0-a10d-495f-a014-f9ff25a6b6f3"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (67457-853-50)  / 5 mL in 1 VIAL", "package_ndc": "67457-853-50", "marketing_start_date": "20180913"}], "brand_name": "Acetazolamide", "product_id": "67457-853_300661cb-a5d8-4edc-a191-72284744e1eb", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "Sulfonamides [CS]"], "product_ndc": "67457-853", "generic_name": "acetazolamide sodium", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetazolamide", "active_ingredients": [{"name": "ACETAZOLAMIDE SODIUM", "strength": "500 mg/5mL"}], "application_number": "ANDA200880", "marketing_category": "ANDA", "marketing_start_date": "20180913", "listing_expiration_date": "20261231"}