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United States · US · US:70710-1478_62ff03a3-fb25-41d8-9c6c-d1ad61ea3d31
Fomepizole
Orange BookUNIISPLATC V03AB34
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeV03AB34
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170710147811 VIAL in 1 CARTON (70710-1478-1) / 1.5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
83LCM6L2BY
FOMEPIZOLE
RxCUI 15226
Orange Book
A078537
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": "70710-1478_62ff03a3-fb25-41d8-9c6c-d1ad61ea3d31",
"productndc": "70710-1478",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "078537",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1.5GM/1.5ML (1GM/ML)",
"product_no": "001",
"approval_date": "Mar 6, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FOMEPIZOLE",
"proprietary_name": "Fomepizole",
"active_ingred_unit": "g/mL",
"application_number": "ANDA078537",
"marketing_category": "ANDA",
"nonproprietary_name": "Fomepizole",
"start_marketing_date": "20210318",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code V03AB34.
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