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United States · US · US:65841-762_bb74273d-215a-4983-bfa1-7d649f6872d5

acetazolamide

Orange BookUNIISPLATC S01EC01

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeS01EC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    6584176201
    100 CAPSULE in 1 BOTTLE (65841-762-01)
  • ndc11
    6584176205
    500 CAPSULE in 1 BOTTLE (65841-762-05)
  • ndc11
    6584176206
    30 CAPSULE in 1 BOTTLE (65841-762-06)
  • ndc11
    6584176210
    1000 CAPSULE in 1 BOTTLE (65841-762-10)
  • ndc11
    6584176216
    90 CAPSULE in 1 BOTTLE (65841-762-16)
  • ndc11
    6584176230
    10 BLISTER PACK in 1 CARTON (65841-762-30) / 10 CAPSULE in 1 BLISTER PACK

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": "65841-762_bb74273d-215a-4983-bfa1-7d649f6872d5",
  "productndc": "65841-762",
  "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": "20190410",
  "active_numerator_strength": "500"
}

Related drugs

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