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United States · US · US:50742-233_7b0e4b3b-5f80-43bb-8a22-686d8323d86e

Acetazolamide

Orange BookUNIISPLATC S01EC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerIngenus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeS01EC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5074223301
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-233-01)

Annotations

UNII (FDA Substance ID)
O3FX965V0I
ACETAZOLAMIDE
RxCUI 167
Orange Book
A203434
AB
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": "50742-233_7b0e4b3b-5f80-43bb-8a22-686d8323d86e",
  "productndc": "50742-233",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203434",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Sep 30, 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": "ANDA203434",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetazolamide",
  "start_marketing_date": "20170731",
  "active_numerator_strength": "500"
}

Related drugs

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