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United States · US · US:67457-853_300661cb-a5d8-4edc-a191-72284744e1eb

Acetazolamide

Orange BookUNIISPLATC S01EC01

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

Identification

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

Packs · 1

  • ndc11
    6745785350
    1 VIAL in 1 CARTON (67457-853-50) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
429ZT169UH
ACETAZOLAMIDE SODIUM
RxCUI 91406
Orange Book
A200880
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "429ZT169UH",
    "rxcui": "91406",
    "inchikey": "MRSXAJAOWWFZJJ-UHFFFAOYSA-M",
    "display_name": "ACETAZOLAMIDE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "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": "67457-853_300661cb-a5d8-4edc-a191-72284744e1eb",
  "productndc": "67457-853",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "200880",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 9, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAZOLAMIDE SODIUM",
  "proprietary_name": "Acetazolamide",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA200880",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetazolamide sodium",
  "start_marketing_date": "20180913",
  "active_numerator_strength": "500"
}

Related drugs

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