acetazolamide

Generic: acetazolamide

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetazolamide
Generic Name acetazolamide
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetazolamide 500 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-349
Product ID 46708-349_d9c1cc75-4e3d-4eaf-87c5-d5942a843818
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210423
Listing Expiration 2026-12-31
Marketing Start 2019-02-20

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 46708349
Hyphenated Format 46708-349

Supplemental Identifiers

RxCUI
562524
UPC
0346708349318
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 ANDA210423 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-31)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-91)
source: ndc

Packages (2)

46708-349-31 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-31) 46708-349-91 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-91)

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": "d9c1cc75-4e3d-4eaf-87c5-d5942a843818", "openfda": {"nui": ["N0000175517", "N0000000235", "M0020790"], "upc": ["0346708349318"], "unii": ["O3FX965V0I"], "rxcui": ["562524"], "spl_set_id": ["d9c1cc75-4e3d-4eaf-87c5-d5942a843818"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Carbonic Anhydrase Inhibitor [EPC]"], "pharm_class_moa": ["Carbonic Anhydrase Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-31)", "package_ndc": "46708-349-31", "marketing_start_date": "20190220"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-91)", "package_ndc": "46708-349-91", "marketing_start_date": "20190220"}], "brand_name": "Acetazolamide", "product_id": "46708-349_d9c1cc75-4e3d-4eaf-87c5-d5942a843818", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "Sulfonamides [CS]"], "product_ndc": "46708-349", "generic_name": "Acetazolamide", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetazolamide", "active_ingredients": [{"name": "ACETAZOLAMIDE", "strength": "500 mg/1"}], "application_number": "ANDA210423", "marketing_category": "ANDA", "marketing_start_date": "20190220", "listing_expiration_date": "20261231"}