ACETAZOLAMIDE

Orange BookUNIISPLATC S01EC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeS01EC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5965190601
100 TABLET in 1 BOTTLE (59651-906-01)

Annotations

UNII (FDA Substance ID)

O3FX965V0I

ACETAZOLAMIDE

RxCUI 167

Orange Book

A212089

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "O3FX965V0I",
    "rxcui": "167",
    "inchikey": "BZKPWHYZMXOIDC-UHFFFAOYSA-N",
    "display_name": "ACETAZOLAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c5acf531-ba55-47b7-88db-e5da0206ebf1": {
      "match": "brand_token",
      "title": "ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]",
      "spl_version": "5",
      "published_date": "2026-05-25"
    }
  },
  "productid": "59651-906_0392e11a-1290-442f-9765-e1f79ec43eae",
  "productndc": "59651-906",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212089",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "May 30, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "May 30, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAZOLAMIDE",
  "proprietary_name": "ACETAZOLAMIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212089",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ACETAZOLAMIDE",
  "start_marketing_date": "20250530",
  "active_numerator_strength": "250"
}

Related drugs

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