🇺🇸
United States · US · US:0517-0710_aac796de-58f6-49e5-b959-f95b0c7b8889
fomepizole
Orange BookUNIISPLATC V03AB34
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Regent, Inc.
CountryUS (United States)
ATC codeV03AB34
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105170710881 VIAL in 1 CARTON (0517-0710-88) / 1.5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
83LCM6L2BY
FOMEPIZOLE
RxCUI 15226
Orange Book
A078368
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "83LCM6L2BY",
"rxcui": "15226",
"inchikey": "RIKMMFOAQPJVMX-UHFFFAOYSA-N",
"display_name": "FOMEPIZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"256910fe-91f2-48f6-b0b4-55edc52dacd4": {
"match": "brand_token",
"title": "FOMEPIZOLE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]",
"spl_version": "8",
"published_date": "2025-11-21"
}
},
"productid": "0517-0710_aac796de-58f6-49e5-b959-f95b0c7b8889",
"productndc": "0517-0710",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "078368",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1.5GM/1.5ML (1GM/ML)",
"product_no": "001",
"approval_date": "Dec 14, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FOMEPIZOLE",
"proprietary_name": "fomepizole",
"active_ingred_unit": "g/mL",
"application_number": "ANDA078368",
"marketing_category": "ANDA",
"nonproprietary_name": "fomepizole",
"start_marketing_date": "20200731",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code V03AB34.
- CAANTIZOLENDO OPERATIONS LTD.
- GBAntizol 1.5g/1.5ml solution for infusion vialsImported (United States)
- 🇺🇸fomepizoleAmerican Regent, Inc.
- 🇺🇸FomepizoleGland Pharma Limited
- 🇺🇸FomepizoleMylan Institutional LLC
- 🇺🇸FomepizoleNavinta LLC
- 🇺🇸FomepizoleSagent Pharmaceuticals
- 🇺🇸FomepizoleZydus Pharmaceuticals USA Inc.
Access this data programmatically
Query fomepizole and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.