acetazolamide extended-release

Generic: acetazolamide extended-release

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetazolamide extended-release
Generic Name acetazolamide extended-release
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

acetazolamide 500 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-042
Product ID 50268-042_0e84c7df-dbb4-d445-e063-6394a90ab528
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207401
Listing Expiration 2026-12-31
Marketing Start 2022-07-20

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 50268042
Hyphenated Format 50268-042

Supplemental Identifiers

RxCUI
562524
UNII
O3FX965V0I
NUI
N0000175517 N0000000235 M0020790

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 extended-release (source: ndc)
Generic Name acetazolamide extended-release (source: ndc)
Application Number ANDA207401 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 BOX (50268-042-12) / 1 CAPSULE in 1 BLISTER PACK (50268-042-11)
source: ndc

Packages (1)

50268-042-12 20 BLISTER PACK in 1 BOX (50268-042-12) / 1 CAPSULE in 1 BLISTER PACK (50268-042-11)

Ingredients (1)

acetazolamide (500 mg/1)

Linked Drug Pages (1)

ACETAZOLAMIDE EXTENDED-RELEASE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e84c7df-dbb4-d445-e063-6394a90ab528", "openfda": {"nui": ["N0000175517", "N0000000235", "M0020790"], "unii": ["O3FX965V0I"], "rxcui": ["562524"], "spl_set_id": ["e43f991d-15b9-1e66-e053-2a95a90a9449"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Carbonic Anhydrase Inhibitor [EPC]"], "pharm_class_moa": ["Carbonic Anhydrase Inhibitors [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 BOX (50268-042-12)  / 1 CAPSULE in 1 BLISTER PACK (50268-042-11)", "package_ndc": "50268-042-12", "marketing_start_date": "20220720"}], "brand_name": "ACETAZOLAMIDE EXTENDED-RELEASE", "product_id": "50268-042_0e84c7df-dbb4-d445-e063-6394a90ab528", "dosage_form": "CAPSULE", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "Sulfonamides [CS]"], "product_ndc": "50268-042", "generic_name": "Acetazolamide Extended-Release", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACETAZOLAMIDE EXTENDED-RELEASE", "active_ingredients": [{"name": "ACETAZOLAMIDE", "strength": "500 mg/1"}], "application_number": "ANDA207401", "marketing_category": "ANDA", "marketing_start_date": "20220720", "listing_expiration_date": "20261231"}