acetazolamide

Orange BookUNIISPLATC S01EC01

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

Identification

ManufacturerMajor Pharmaceuticals

CountryUS (United States)

ATC codeS01EC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0904666361
100 BLISTER PACK in 1 CARTON (0904-6663-61) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

O3FX965V0I

ACETAZOLAMIDE

RxCUI 167

Orange Book

A205530

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": "0904-6663_6ac9aecc-c4b1-4fd4-88c0-2d83cf584743",
  "productndc": "0904-6663",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205530",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "Oct 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Oct 27, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAZOLAMIDE",
  "proprietary_name": "acetazolamide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205530",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetazolamide",
  "start_marketing_date": "20130315",
  "active_numerator_strength": "250"
}

Related drugs

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