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United States · US · US:62332-349_5e12d289-e62f-4b85-a419-ec24a39049ba

Acetazolamide

Orange BookUNIISPLATC S01EC01

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeS01EC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6233234931
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-349-31)
  • ndc11
    6233234991
    1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-349-91)

Annotations

UNII (FDA Substance ID)
O3FX965V0I
ACETAZOLAMIDE
RxCUI 167
Orange Book
A210423
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": "62332-349_5e12d289-e62f-4b85-a419-ec24a39049ba",
  "productndc": "62332-349",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210423",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Feb 19, 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": "ANDA210423",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetazolamide",
  "start_marketing_date": "20190220",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code S01EC01.

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