acetazolamide

Generic: acetazolamide

Labeler: marlex pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetazolamide
Generic Name acetazolamide
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetazolamide 125 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-830
Product ID 10135-830_4a03f386-e570-d4cb-e063-6394a90a8228
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217197
Listing Expiration 2027-12-31
Marketing Start 2026-02-01

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 10135830
Hyphenated Format 10135-830

Supplemental Identifiers

RxCUI
197303 197304
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 ANDA217197 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (10135-830-01)
source: ndc

Packages (1)

10135-830-01 100 TABLET in 1 BOTTLE (10135-830-01)

Ingredients (1)

acetazolamide (125 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": "4a03f386-e570-d4cb-e063-6394a90a8228", "openfda": {"nui": ["N0000175517", "N0000000235", "M0020790"], "unii": ["O3FX965V0I"], "rxcui": ["197303", "197304"], "spl_set_id": ["4a03f35d-bfcb-77ff-e063-6294a90a4f06"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Carbonic Anhydrase Inhibitor [EPC]"], "pharm_class_moa": ["Carbonic Anhydrase Inhibitors [MoA]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10135-830-01)", "package_ndc": "10135-830-01", "marketing_start_date": "20260201"}], "brand_name": "Acetazolamide", "product_id": "10135-830_4a03f386-e570-d4cb-e063-6394a90a8228", "dosage_form": "TABLET", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "Sulfonamides [CS]"], "product_ndc": "10135-830", "generic_name": "Acetazolamide", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetazolamide", "active_ingredients": [{"name": "ACETAZOLAMIDE", "strength": "125 mg/1"}], "application_number": "ANDA217197", "marketing_category": "ANDA", "marketing_start_date": "20260201", "listing_expiration_date": "20271231"}