FDA.reportPublic FDA data

Leuprolide Acetate

Product NDC
83634-454
11-digit product format
836340454
Labeler code
83634
Product ID
83634-454_9ad77738-6d76-4efb-96af-e9848794b07a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
leuprolide acetate
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
Avenacy, LLC
Application
ANDA217957
Marketing category
ANDA
Marketing start
2025-03-15
Marketing end
2026-06-30
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct83634-454DDiscontinued by firm2026-08-10
excluded packagepackage83634-45483634-454-61DDiscontinued by firm2026-08-10

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
A217957-001LEUPROLIDE ACETATELEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2024-10-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217957-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217957-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2024-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217957-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2024-10-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A217957-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2024-10-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217957-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2024-10-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217957-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2024-10-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217957-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2024-10-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217957-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2024-10-172680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217957-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2024-10-17d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217957-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2024-10-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217957-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217957-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217957-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217957-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217957-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217957-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217957-001AP12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217957-001AP1d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217957-001AP1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e666f57-491f-16e0-fc75-cc1c9f2fe06fProduct name420250515
43944b95-6cc2-4eca-846a-a5e0ed070616Product name120240501
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5Product name120230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
2ed2d111-4d16-4e2a-9b09-7d196056f6c9Product name120211214
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26Product name120200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
ae18ed71-8057-40ec-987f-83624e50b906Product name120150122
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83634-452-03Leuprolide Acetate2.8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.8 mL5 mg in 1mL3
83634-453-01Leuprolide Acetate1 mL in 1 PACKETSWAB28 mL0.7 mL in 1mL3
83634-454-61Leuprolide Acetate1 in 1 CARTONKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83634-454-61EA - Each83634-45409c80231-62ad-47d4-9132-516cfd24569f12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-454LEUPROLIDE ACETATE KIT [AVENACY INC.]1Current NDC, 3 package rows20250316_15003c37-6e91-4c79-a85c-3d03343b53f9.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leuprolide acetateLEUPROLIDE ACETATEUBI Pharma Inc.cd46628f-055f-4da9-8c38-fa69af34eb4d2026-03-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217957
application number: ANDA217957
leuprolide acetateLEUPROLIDE ACETATEPAI Holdings, LLC dba PAI Pharma19be0b7f-e68a-4547-9e49-b51b128219072026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217957
application number: ANDA217957

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN15003c37-6e91-4c79-a85c-3d03343b53f93
545835leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable SolutionPSN15003c37-6e91-4c79-a85c-3d03343b53f93
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD15003c37-6e91-4c79-a85c-3d03343b53f93
545835leuprolide acetate 5 MG/ML Injectable SolutionSCD15003c37-6e91-4c79-a85c-3d03343b53f93
797544isopropyl alcohol 70 % Medicated PadSY15003c37-6e91-4c79-a85c-3d03343b53f93
797544isopropyl alcohol 70 % Topical ClothSY15003c37-6e91-4c79-a85c-3d03343b53f93
797544isopropyl alcohol 70 % Topical SwabSY15003c37-6e91-4c79-a85c-3d03343b53f93
545835leuprolide acetate 1 MG per 0.2 ML Injectable SolutionSY15003c37-6e91-4c79-a85c-3d03343b53f93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83634-452-03836340452032.8 mL in 1 VIAL, MULTI-DOSE2.8 mlHistorical
83634-453-01836340453011 mL in 1 PACKET1 mlHistorical
83634-454-61836340454611 KIT in 1 CARTON (83634-454-61) * 2.8 mL in 1 VIAL, MULTI-DOSE (83634-452-03) * 1 mL in 1 PACKET (83634-453-01) 1 kit2025-10-152026-06-30NoNoHistorical