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United States · US · US:60687-578_365ff016-96db-785d-e063-6394a90aaada

acetazolamide

Orange BookUNIISPLATC S01EC01

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeS01EC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6068757821
    30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-578-21) / 1 CAPSULE in 1 BLISTER PACK (60687-578-11)

Annotations

UNII (FDA Substance ID)
O3FX965V0I
ACETAZOLAMIDE
RxCUI 167
Orange Book
A205301
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": "60687-578_365ff016-96db-785d-e063-6394a90aaada",
  "productndc": "60687-578",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205301",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jan 16, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAZOLAMIDE",
  "proprietary_name": "acetazolamide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205301",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetazolamide",
  "start_marketing_date": "20201027",
  "active_numerator_strength": "500"
}

Related drugs

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