acetazolamide

Generic: acetazolamide

Labeler: aarkish pharmaceuticals nj inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetazolamide
Generic Name acetazolamide
Labeler aarkish pharmaceuticals nj inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetazolamide 250 mg/1

Manufacturer
Aarkish Pharmaceuticals NJ Inc.

Identifiers & Regulatory

Product NDC 81005-105
Product ID 81005-105_45753e50-34f0-97e1-e063-6394a90abd3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217197
Listing Expiration 2026-12-31
Marketing Start 2024-12-03

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 81005105
Hyphenated Format 81005-105

Supplemental Identifiers

RxCUI
197303 197304
UPC
0381005105014 0381005105106 0381005104109
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
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (81005-105-01)
  • 1000 TABLET in 1 BOTTLE (81005-105-10)
source: ndc

Packages (2)

81005-105-01 100 TABLET in 1 BOTTLE (81005-105-01) 81005-105-10 1000 TABLET in 1 BOTTLE (81005-105-10)

Ingredients (1)

acetazolamide (250 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": "45753e50-34f0-97e1-e063-6394a90abd3d", "openfda": {"nui": ["N0000175517", "N0000000235", "M0020790"], "upc": ["0381005105014", "0381005105106", "0381005104109"], "unii": ["O3FX965V0I"], "rxcui": ["197303", "197304"], "spl_set_id": ["ddfd44dc-3136-4dda-8ed0-eb2991c2a0b6"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Carbonic Anhydrase Inhibitor [EPC]"], "pharm_class_moa": ["Carbonic Anhydrase Inhibitors [MoA]"], "manufacturer_name": ["Aarkish Pharmaceuticals NJ Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (81005-105-01)", "package_ndc": "81005-105-01", "marketing_start_date": "20241203"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (81005-105-10)", "package_ndc": "81005-105-10", "marketing_start_date": "20241203"}], "brand_name": "Acetazolamide", "product_id": "81005-105_45753e50-34f0-97e1-e063-6394a90abd3d", "dosage_form": "TABLET", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "Sulfonamides [CS]"], "product_ndc": "81005-105", "generic_name": "Acetazolamide", "labeler_name": "Aarkish Pharmaceuticals NJ Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetazolamide", "active_ingredients": [{"name": "ACETAZOLAMIDE", "strength": "250 mg/1"}], "application_number": "ANDA217197", "marketing_category": "ANDA", "marketing_start_date": "20241203", "listing_expiration_date": "20261231"}