acetaZOLAMIDE

Orange BookUNIISPLATC S01EC01

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeS01EC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009075360
12 TABLET in 1 BOTTLE (50090-7536-0)

Annotations

UNII (FDA Substance ID)

O3FX965V0I

ACETAZOLAMIDE

RxCUI 167

Orange Book

A211069

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": "50090-7536_0c0d69e8-f78e-4286-ad4a-77e3719e16ac",
  "productndc": "50090-7536",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211069",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "Apr 4, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Apr 4, 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": "ANDA211069",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetaZOLAMIDE",
  "start_marketing_date": "20230715",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code S01EC01.

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