🇺🇸
United States · US · US:43598-773_2f5844a8-825f-6a4f-996e-17e21c369359
LEVOLEUCOVORIN
Orange BookUNIISPLATC V03AF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddy's Laboratories Inc
CountryUS (United States)
ATC codeV03AF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143598773111 VIAL, SINGLE-DOSE in 1 CARTON (43598-773-11) / 25 mL in 1 VIAL, SINGLE-DOSE
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": "43598-773_2f5844a8-825f-6a4f-996e-17e21c369359",
"productndc": "43598-773",
"dosage_form": "INJECTION, SOLUTION",
"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/25mL",
"application_number": "ANDA210892",
"marketing_category": "ANDA",
"nonproprietary_name": "LEVOLEUCOVORIN",
"start_marketing_date": "20180926",
"active_numerator_strength": "250"
}Related drugs
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- BEElvorine 7.5 mgPfizer
- DKIsovorinParanova Danmark A/S
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