acetazolamide

Generic: acetazolamide

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetazolamide
Generic Name acetazolamide
Labeler accord healthcare inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetazolamide 500 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-331
Product ID 16729-331_45ffaa19-26c0-d41f-e063-6394a90ad7c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207659
Listing Expiration 2026-12-31
Marketing Start 2021-11-19

Pharmacologic Class

Established (EPC)
carbonic anhydrase inhibitor [epc]
Mechanism of Action
carbonic anhydrase inhibitors [moa]
Chemical Structure
sulfonamides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729331
Hyphenated Format 16729-331

Supplemental Identifiers

RxCUI
562524
UNII
O3FX965V0I
NUI
N0000175517 N0000000235 M0020790

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 ANDA207659 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-331-01)
source: ndc

Packages (1)

16729-331-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-331-01)

Ingredients (1)

acetazolamide (500 mg/1)

Linked Drug Pages (1)

acetazolamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45ffaa19-26c0-d41f-e063-6394a90ad7c3", "openfda": {"nui": ["N0000175517", "N0000000235", "M0020790"], "unii": ["O3FX965V0I"], "rxcui": ["562524"], "spl_set_id": ["9a368b35-cd51-47ad-83cc-ccc56c4585e8"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Carbonic Anhydrase Inhibitor [EPC]"], "pharm_class_moa": ["Carbonic Anhydrase Inhibitors [MoA]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-331-01)", "package_ndc": "16729-331-01", "marketing_start_date": "20211119"}], "brand_name": "acetazolamide", "product_id": "16729-331_45ffaa19-26c0-d41f-e063-6394a90ad7c3", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "Sulfonamides [CS]"], "product_ndc": "16729-331", "generic_name": "acetazolamide", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "acetazolamide", "active_ingredients": [{"name": "ACETAZOLAMIDE", "strength": "500 mg/1"}], "application_number": "ANDA207659", "marketing_category": "ANDA", "marketing_start_date": "20211119", "listing_expiration_date": "20261231"}