🇺🇸
United States · US · US:68083-279_c3b9daf5-c553-46af-b651-841b43b2e706
levoleucovorin
Orange BookUNIISPLATC V03AF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeV03AF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083279011 VIAL in 1 CARTON (68083-279-01) / 25 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
778XL6VBS8
LEVOLEUCOVORIN CALCIUM
RxCUI 979509
Orange Book
A210892
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "778XL6VBS8",
"rxcui": "979509",
"inchikey": "KVUAALJSMIVURS-QNTKWALQSA-L",
"display_name": "LEVOLEUCOVORIN CALCIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"0c67eeae-3090-473d-b712-b9a83dc77b72": {
"match": "brand_token",
"title": "LEVOLEUCOVORIN CALCIUM (LEVOLEUCOVORIN) INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC]",
"spl_version": "12",
"published_date": "2024-08-08"
}
},
"productid": "68083-279_c3b9daf5-c553-46af-b651-841b43b2e706",
"productndc": "68083-279",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "210892",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)",
"product_no": "001",
"approval_date": "Sep 14, 2018"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG BASE/25ML (EQ 10MG BASE/ML)",
"product_no": "002",
"approval_date": "Sep 14, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOLEUCOVORIN CALCIUM",
"proprietary_name": "levoleucovorin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA210892",
"marketing_category": "ANDA",
"nonproprietary_name": "Levoleucovorin",
"start_marketing_date": "20180920",
"active_numerator_strength": "10"
}Related drugs
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