FDA.reportPublic FDA data

Vabrinty

Product NDC
85043-075
11-digit product format
850430075
Labeler code
85043
Product ID
85043-075_b8da8614-75a8-453c-be31-0568da16a3b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leuprolide acetate
Dosage form
INJECTION, SUSPENSION, EXTENDED RELEASE
Route
SUBCUTANEOUS
Labeler
URONOVA PHARMACEUTICALS, INC.
Application
NDA021343
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-12-15
Substance
LEUPROLIDE ACETATE
Active strength
7.5 mg/.25mL
Pharmacologic classes
Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vabrinty
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUPROLIDE ACETATE7.5 mg/.25mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii37JNS02E7V
Rxcui752889, 752894, 752899, 2720345, 2720348, 2723399, 2728996, 752884

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e666f57-491f-16e0-fc75-cc1c9f2fe06fProduct name420250515
43944b95-6cc2-4eca-846a-a5e0ed070616Product name120240501
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5Product name120230829
2ed2d111-4d16-4e2a-9b09-7d196056f6c9Product name120211214
ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26Product name120200925
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
ae18ed71-8057-40ec-987f-83624e50b906Product name120150122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85043-075-05Vabrinty1 in 1 CARTONINJECTION, SUSPENSION, EXTENDED19
85043-075-05Vabrinty0.25 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED0.259
85043-075-50Vabrinty1 in 1 CARTONINJECTION, SUSPENSION, EXTENDED19
85043-075-50Vabrinty0.25 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED0.259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85043-075-05EA - Each85043-0752d17d2b8-86ab-4ad5-89cc-264ad68e782912026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
752894leuprolide acetate 22.5 MG in 0.375 mL (3 month) Prefilled SyringePSN008776cc-83f1-4f8c-819b-6471425da15f9
752889leuprolide acetate 30 MG in 0.5 ML (4 month) Prefilled SyringePSN008776cc-83f1-4f8c-819b-6471425da15f9
752884leuprolide acetate 45 MG in 0.375 ML (6 month) Prefilled SyringePSN008776cc-83f1-4f8c-819b-6471425da15f9
752899leuprolide acetate 7.5 MG in 0.25 ML (1 month) Prefilled SyringePSN008776cc-83f1-4f8c-819b-6471425da15f9
2720345Vabrinty 22.5 MG in 0.375 ML (3 month) Prefilled SyringePSN008776cc-83f1-4f8c-819b-6471425da15f9
2723399Vabrinty 30 MG in 0.5 ML (4 month) Prefilled SyringePSN008776cc-83f1-4f8c-819b-6471425da15f9
2720348Vabrinty 45 MG in 0.375 ML (6 month) Prefilled SyringePSN008776cc-83f1-4f8c-819b-6471425da15f9
2728996Vabrinty 7.5 MG in 0.25 ML (1 month) Prefilled SyringePSN008776cc-83f1-4f8c-819b-6471425da15f9
27289960.25 ML leuprolide acetate 30 MG/ML Prefilled Syringe [Vabrinty]SBD008776cc-83f1-4f8c-819b-6471425da15f9
27203480.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe [Vabrinty]SBD008776cc-83f1-4f8c-819b-6471425da15f9
27203450.375 ML leuprolide acetate 60 MG/ML Prefilled Syringe [Vabrinty]SBD008776cc-83f1-4f8c-819b-6471425da15f9
27233990.5 ML leuprolide acetate 60 MG/ML Prefilled Syringe [Vabrinty]SBD008776cc-83f1-4f8c-819b-6471425da15f9
7528990.25 ML leuprolide acetate 30 MG/ML Prefilled SyringeSCD008776cc-83f1-4f8c-819b-6471425da15f9
7528840.375 ML leuprolide acetate 120 MG/ML Prefilled SyringeSCD008776cc-83f1-4f8c-819b-6471425da15f9
7528940.375 ML leuprolide acetate 60 MG/ML Prefilled SyringeSCD008776cc-83f1-4f8c-819b-6471425da15f9
7528890.5 ML leuprolide acetate 60 MG/ML Prefilled SyringeSCD008776cc-83f1-4f8c-819b-6471425da15f9
27289960.25 ML Vabrinty 30 MG/ML Prefilled SyringeSY008776cc-83f1-4f8c-819b-6471425da15f9
752894leuprolide acetate 22.5 MG per 0.375 ML (3 month) Prefilled SyringeSY008776cc-83f1-4f8c-819b-6471425da15f9
752894leuprolide acetate 22.5 MG per 0.375 ML Prefilled SyringeSY008776cc-83f1-4f8c-819b-6471425da15f9
752889leuprolide acetate 30 MG per 0.5 ML (4 month) Prefilled SyringeSY008776cc-83f1-4f8c-819b-6471425da15f9
752884leuprolide acetate 45 MG per 0.375 ML (6 month) Prefilled SyringeSY008776cc-83f1-4f8c-819b-6471425da15f9
752884leuprolide acetate 45 MG per 0.375 ML Prefilled SyringeSY008776cc-83f1-4f8c-819b-6471425da15f9
752899leuprolide acetate 7.5 MG per 0.25 ML Prefilled SyringeSY008776cc-83f1-4f8c-819b-6471425da15f9
2720345Vabrinty 22.5 MG per 0.375 ML Prefilled SyringeSY008776cc-83f1-4f8c-819b-6471425da15f9
2723399Vabrinty 30 MG per 0.5 ML Prefilled SyringeSY008776cc-83f1-4f8c-819b-6471425da15f9
2720348Vabrinty 45 MG per 0.375 ML Prefilled SyringeSY008776cc-83f1-4f8c-819b-6471425da15f9
2728996Vabrinty 7.5 MG per 0.25 ML Prefilled SyringeSY008776cc-83f1-4f8c-819b-6471425da15f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85043-075-05850430075051 SYRINGE in 1 CARTON (85043-075-05) / .25 mL in 1 SYRINGE1 syringe2025-12-15NoNoHistorical
85043-075-50850430075501 SYRINGE in 1 CARTON (85043-075-50) / .25 mL in 1 SYRINGE1 syringe2026-02-02YesNoHistorical