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United States · US · US:25021-204_dfa03517-f452-450c-8eb6-d946c0350248
Vinorelbine
Orange BookUNIISPLATC L01CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeL01CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1125021204011 VIAL in 1 CARTON (25021-204-01) / 1 mL in 1 VIAL
- ndc1125021204051 VIAL in 1 CARTON (25021-204-05) / 5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
253GQW851Q
VINORELBINE TARTRATE
RxCUI 114527
Orange Book
A091106
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "253GQW851Q",
"rxcui": "114527",
"inchikey": "CILBMBUYJCWATM-PYGJLNRPSA-N",
"display_name": "VINORELBINE TARTRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"10a70995-e04d-4044-b1dc-c9aa27460397": {
"match": "brand_token",
"title": "VINORELBINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]",
"spl_version": "10",
"published_date": "2024-09-18"
}
},
"productid": "25021-204_dfa03517-f452-450c-8eb6-d946c0350248",
"productndc": "25021-204",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "091106",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 10MG BASE/ML",
"product_no": "001",
"approval_date": "Sep 26, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VINORELBINE TARTRATE",
"proprietary_name": "Vinorelbine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA091106",
"marketing_category": "ANDA",
"nonproprietary_name": "Vinorelbine",
"start_marketing_date": "20140915",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code L01CA04.
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