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United States · US · US:85043-025_b8da8614-75a8-453c-be31-0568da16a3b9
Vabrinty
Orange BookUNIISPLATC L02AE02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerURONOVA PHARMACEUTICALS, INC.
CountryUS (United States)
ATC codeL02AE02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1185043025021 SYRINGE in 1 CARTON (85043-025-02) / .375 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
37JNS02E7V
LEUPROLIDE ACETATE
RxCUI 203217
Orange Book
N021379
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "37JNS02E7V",
"rxcui": "203217",
"inchikey": "RGLRXNKKBLIBQS-XNHQSDQCSA-N",
"display_name": "LEUPROLIDE ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"008776cc-83f1-4f8c-819b-6471425da15f": {
"match": "brand_token",
"title": "VABRINTY (LEUPROLIDE ACETATE) INJECTION, SUSPENSION, EXTENDED RELEASE [URONOVA PHARMACEUTICALS, INC.]",
"spl_version": "9",
"published_date": "2026-01-28"
}
},
"productid": "85043-025_b8da8614-75a8-453c-be31-0568da16a3b9",
"productndc": "85043-025",
"dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"orange_book": {
"appl_no": "021379",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "22.5MG",
"product_no": "001",
"approval_date": "Jul 24, 2002"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEUPROLIDE ACETATE",
"proprietary_name": "Vabrinty",
"active_ingred_unit": "mg/.375mL",
"application_number": "NDA021379",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Leuprolide acetate",
"start_marketing_date": "20250804",
"active_numerator_strength": "22.5"
}Related drugs
Other records sharing ATC code L02AE02.
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