🇺🇸
United States · US · US:70436-209_041b2b7e-33b8-a347-e063-6394a90acbc2
LEVOLEUCOVORIN CALCIUM
Orange BookUNIISPLATC V03AF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSlate Run Pharmaceuticals
CountryUS (United States)
ATC codeV03AF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170436209801 VIAL, SINGLE-DOSE in 1 CARTON (70436-209-80) / 17.5 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
778XL6VBS8
LEVOLEUCOVORIN CALCIUM
RxCUI 979509
Orange Book
A217314
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": "70436-209_041b2b7e-33b8-a347-e063-6394a90acbc2",
"productndc": "70436-209",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "217314",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)",
"product_no": "001",
"approval_date": "May 22, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG BASE/25ML (EQ 10MG BASE/ML)",
"product_no": "002",
"approval_date": "May 22, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOLEUCOVORIN CALCIUM",
"proprietary_name": "LEVOLEUCOVORIN CALCIUM",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA217314",
"marketing_category": "ANDA",
"nonproprietary_name": "levoleucovorin injection",
"start_marketing_date": "20230801",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code V03AF04.
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- 🇫🇷ELVORINE 25 mg/2,5 mL, solution injectablePFIZER HOLDING FRANCE
- BEElvorine 50 mg/5 mlPfizer
- 🇫🇷ELVORINE 50 mg/5 mL, solution injectablePFIZER HOLDING FRANCE
- BEElvorine 7.5 mgPfizer
- DKIsovorinParanova Danmark A/S
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