Acetazolamide

Orange BookUNIISPLATC S01EC01

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

Identification

ManufacturerAarkish Pharmaceuticals NJ Inc.

CountryUS (United States)

ATC codeS01EC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
8100510401
100 TABLET in 1 BOTTLE (81005-104-01)
ndc11
8100510410
1000 TABLET in 1 BOTTLE (81005-104-10)

Annotations

UNII (FDA Substance ID)

O3FX965V0I

ACETAZOLAMIDE

RxCUI 167

Orange Book

A217197

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": "81005-104_45753e50-34f0-97e1-e063-6394a90abd3d",
  "productndc": "81005-104",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217197",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "May 9, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "May 9, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAZOLAMIDE",
  "proprietary_name": "Acetazolamide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217197",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetazolamide",
  "start_marketing_date": "20241203",
  "active_numerator_strength": "125"
}

Related drugs

Other records sharing ATC code S01EC01.

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