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United States · US · US:42571-243_456f5ce4-6ad1-f0a1-e063-6294a90a0fac

ACETAZOLAMIDE EXTENDED-RELEASE

Orange BookUNIISPLATC S01EC01

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

Identification

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

Packs · 1

  • ndc11
    4257124301
    100 CAPSULE in 1 BOTTLE (42571-243-01)

Annotations

UNII (FDA Substance ID)
O3FX965V0I
ACETAZOLAMIDE
RxCUI 167
Orange Book
A207401
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": "42571-243_456f5ce4-6ad1-f0a1-e063-6294a90a0fac",
  "productndc": "42571-243",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207401",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Oct 1, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAZOLAMIDE",
  "proprietary_name": "ACETAZOLAMIDE EXTENDED-RELEASE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207401",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetazolamide extended-release",
  "start_marketing_date": "20201201",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code S01EC01.

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