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United States · US · US:68462-767_79d023ab-7d77-48c1-8f47-ea322fd58c2b
Leucovorin Calcium
Orange BookUNIISPLATC V03AF03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGLENMARK PHARMACEUTICALS INC., USA
CountryUS (United States)
ATC codeV03AF03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168462767351 VIAL in 1 CARTON (68462-767-35) / 17.5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
RPR1R4C0P4
LEUCOVORIN CALCIUM
RxCUI 225852
Orange Book
A218200
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "RPR1R4C0P4",
"rxcui": "225852",
"inchikey": "KVUAALJSMIVURS-ZEDZUCNESA-L",
"display_name": "LEUCOVORIN CALCIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"94669fc8-3c1c-4228-be27-09a1cd468c36": {
"match": "brand_token",
"title": "LEUCOVORIN CALCIUM TABLET [TEVA PHARMACEUTICALS USA, INC.]",
"spl_version": "18",
"published_date": "2026-04-21"
}
},
"productid": "68462-767_79d023ab-7d77-48c1-8f47-ea322fd58c2b",
"productndc": "68462-767",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "218200",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 350MG BASE/VIAL",
"product_no": "001",
"approval_date": "Nov 12, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEUCOVORIN CALCIUM",
"proprietary_name": "Leucovorin Calcium",
"active_ingred_unit": "mg/17.5mL",
"application_number": "ANDA218200",
"marketing_category": "ANDA",
"nonproprietary_name": "Leucovorin Calcium",
"start_marketing_date": "20251112",
"active_numerator_strength": "350"
}Related drugs
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