Home NDC 0185-7400 Leuprolide Acetate
Product NDC 0185-7400
11-digit product format 001857400
Labeler code 0185
Product ID 0185-7400_db12d309-92e5-47f0-84d7-aba74956f6e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Leuprolide Acetate
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Eon Labs, Inc.
Application ANDA074728
Marketing category ANDA
Marketing start 1998-08-04
Marketing end 0000-00-00
Substance LEUPROLIDE ACETATE
Active strength 1 mg/.2mL
Pharmacologic classes Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0185-7400-85 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0185-7400-85 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0185-7400-85 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0185-7400-85 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0185-7400-85 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0185-7400-85 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0185-7400-85 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0185-7400-85 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0185-7400-85 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0185-7400-85 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0185-7400-85 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0185-7400-85 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0185-7400-85 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0185-7400-85 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0185-7400-85 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0185-7400-85 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0185-7400-85 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0185-7400-85 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0185-7400-85 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0185-7400-85 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0185-7400-85 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0185-7400-85 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074728-001 LEUPROLIDE ACETATE LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP RS 1998-08-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074728-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A074728-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP RS 1998-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074728-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP RS 1998-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074728-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP RS 1998-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074728-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP RS 1998-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074728-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP RS 1998-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074728-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP RS 1998-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074728-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP RS 1998-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074728-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP RS 1998-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074728-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP RS 1998-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074728-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP RS 1998-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074728-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP RS 1998-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074728-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP RS 1998-08-04 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEUPROLIDE ACETATE ACTIVE INGREDIENT 37JNS02E7V LEUPROLIDE ACETATE INJECTION, SOLUTION [EON LABS, INC.] 13 LEUPROLIDE ACTIVE MOIETY EFY6W0M8TG LEUPROLIDE ACETATE INJECTION, SOLUTION [EON LABS, INC.] 13 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P LEUPROLIDE ACETATE INJECTION, SOLUTION [EON LABS, INC.] 13 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH LEUPROLIDE ACETATE INJECTION, SOLUTION [EON LABS, INC.] 13 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LEUPROLIDE ACETATE INJECTION, SOLUTION [EON LABS, INC.] 13 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LEUPROLIDE ACETATE INJECTION, SOLUTION [EON LABS, INC.] 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 · 1 matching rows.