Vabrinty

Product NDC
85043-030
11-digit product format
850430030
Labeler code
85043
Product ID
85043-030_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
NDA021488
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-08-04
Substance
LEUPROLIDE ACETATE
Active strength
30 mg/.5mL
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021488-001ELIGARD KITLEUPROLIDE ACETATE30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021488-001117718412041-12-22Drug substance, Drug product2023-10-27
N021488-001119315592041-12-22Drug substance2024-04-15
N021488-001123971202041-12-22U-40012025-09-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021488-001ELIGARD30MG/VIALINJECTABLE / SUBCUTANEOUSRLD, RS2003-02-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021488-001ELIGARD30MG/VIALINJECTABLE / SUBCUTANEOUSRLD, RS2003-02-133f01610625f2…
2019-09-15 20:21 UTC2019-09N021488-001ELIGARD30MG/VIALINJECTABLE / SUBCUTANEOUSRLD, RS2003-02-13b00525d2431f…
2019-07-19 19:46 UTC2019-07N021488-001ELIGARD30MG/VIALINJECTABLE / SUBCUTANEOUSRLD, RS2003-02-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-133f0d92c62455…
2023-05-13 08:27 UTC2023-05N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13053a50430f4f…
2023-01-26 05:58 UTC2023-01N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021488-001ELIGARD KIT30MGPOWDER / SUBCUTANEOUSRLD, RS2003-02-13cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 79 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021488-001117718412041-12-22Drug substance, Drug product2023-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021488-001119315592041-12-22Drug substance2024-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021488-001123971202041-12-22U-40012025-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021488-001117718412041-12-22Drug substance, Drug product2023-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021488-001119315592041-12-22Drug substance2024-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021488-001123971202041-12-22U-40012025-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021488-001117718412041-12-22Drug substance, Drug product2023-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021488-001119315592041-12-22Drug substance2024-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021488-001117718412041-12-22Drug substance, Drug product2023-10-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021488-001119315592041-12-22Drug substance2024-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021488-001117718412041-12-22Drug substance, Drug product2023-10-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021488-001119315592041-12-22Drug substance2024-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021488-001117718412041-12-22Drug substance, Drug product2023-10-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021488-001119315592041-12-22Drug substance2024-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021488-001117718412041-12-22Drug substance, Drug product2023-10-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021488-001119315592041-12-22Drug substance2024-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021488-001117718412041-12-22Drug substance, Drug product2023-10-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021488-001119315592041-12-22Drug substance2024-04-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021488-001117718412041-12-22Drug substance, Drug product2023-10-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021488-001119315592041-12-22Drug substance2024-04-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021488-001117718412041-12-22Drug substance, Drug product2023-10-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N021488-001119315592041-12-22Drug substance2024-04-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021488-001117718412041-12-22Drug substance, Drug product2023-10-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021488-001119315592041-12-22Drug substance2024-04-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021488-001117718412041-12-22Drug substance, Drug product2023-10-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021488-001119315592041-12-22Drug substance2024-04-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021488-001117718412041-12-22Drug substance, Drug product2023-10-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021488-001119315592041-12-22Drug substance2024-04-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021488-001117718412041-12-22Drug substance, Drug product2023-10-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021488-001119315592041-12-22Drug substance2024-04-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021488-00184703592023-10-15U-621Drug substance, Drug product2017-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021488-00184703592023-10-15U-621Drug substance, Drug product2017-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021488-00184703592023-10-15U-621Drug substance, Drug product2017-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021488-00166268702020-03-27Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021488-00188409162020-11-13Drug product2017-01-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021488-00195393332020-11-13U-621Drug substance, Drug product2017-01-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021488-00184703592023-10-15U-621Drug substance, Drug product2017-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021488-00184703592023-10-15U-621Drug substance, Drug product2017-01-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021488-00184703592023-10-15U-621Drug substance, Drug product2017-01-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021488-00184703592023-10-15U-621Drug substance, Drug product2017-01-3187673890dc5c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUPROLIDE ACETATE30 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
37JNS02E7VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
752889Internal RxNorm lookup
752894Internal RxNorm lookup
752899Internal RxNorm lookup
2720345Internal RxNorm lookup
2720348Internal RxNorm lookup
2723399Internal RxNorm lookup
2728996Internal RxNorm lookup
752884Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
008776cc-83f1-4f8c-819b-6471425da15fAvailable on FDA.report

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
85043-030-03Vabrinty1 in 1 CARTONINJECTION, SUSPENSION, EXTENDED19
85043-030-03Vabrinty0.5 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED0.59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85043-030-03EA - Each85043-030d9f24098-629e-4f35-a426-e36fab40151b12025-11-13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VabrintyLEUPROLIDE ACETATEURONOVA PHARMACEUTICALS, INC.008776cc-83f1-4f8c-819b-6471425da15f2026-04-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 021488
application number: NDA021488
ndc (product): 85043-030
EligardLEUPROLIDE ACETATETOLMAR Inc.b7b679a9-6823-4ef8-8d31-3ab5058ffcfc2026-04-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 021488
application number: NDA021488
ELIGARDLEUPROLIDE ACETATETOLMAR Inc.b78d1919-9dee-44fa-90f9-e0a26d32481d2019-04-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 021488
application number: NDA021488

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
85043-030-03850430030031 SYRINGE in 1 CARTON (85043-030-03) / .5 mL in 1 SYRINGE1 syringe2025-08-04NoNoCurrent