🇺🇸
United States · US · US:68083-661_de1a5d68-b82d-4a84-9362-f7edd73f377a
Acetazolamide
Orange BookUNIISPLATC S01EC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeS01EC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083661011 VIAL in 1 CARTON (68083-661-01) / 5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
429ZT169UH
ACETAZOLAMIDE SODIUM
RxCUI 91406
Orange Book
A219775
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": "68083-661_de1a5d68-b82d-4a84-9362-f7edd73f377a",
"productndc": "68083-661",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "219775",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Jun 17, 2025"
}
],
"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": "ANDA219775",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetazolamide",
"start_marketing_date": "20250617",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code S01EC01.
- 🇺🇸acetazolamideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- 🇺🇸acetazolamideNorthwind Health Company, LLC
- 🇺🇸acetazolamideMajor Pharmaceuticals
- 🇺🇸acetazolamideZydus Lifesciences Limited
- 🇺🇸acetazolamideAvKARE
- 🇺🇸acetazolamideA-S Medication Solutions
- 🇺🇸acetazolamideAvKARE
- 🇺🇸acetazolamideAccord Healthcare Inc.
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