Home NDC 71288-569 Leuprolide Acetate
Product NDC 71288-569
11-digit product format 712880569
Labeler code 71288
Product ID 71288-569_fed2b538-4e01-4e4b-9e92-1750554aba61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Leuprolide Acetate
Dosage form KIT
Route SUBCUTANEOUS
Labeler Meitheal Pharmaceuticals Inc
Application ANDA075471
Marketing category ANDA
Marketing start 2024-05-15
NDC exclude flag No
Listing certified through 2026-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075471-001 LEUPROLIDE ACETATE LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2000-10-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075471-001 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 A075471-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2000-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075471-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2000-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075471-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2000-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075471-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2000-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075471-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2000-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075471-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2000-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075471-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2000-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075471-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2000-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075471-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2000-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075471-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2000-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075471-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2000-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075471-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2000-10-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Leuprolide Acetate
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545835 Internal RxNorm lookup 797544 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71288-350-91 Leuprolide Acetate 0.5 mL in 1 PACKET SWAB 14 mL 0.35 mL in 0.5mL 2 71288-565-03 Leuprolide Acetate 2.8 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2.8 mL 5 mg in 1mL 2 71288-565-03 Leuprolide Acetate 1 in 1 CARTON INJECTION, SOLUTION 5 mg in 1mL 2 71288-569-90 Leuprolide Acetate 1 in 1 CARTON KIT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-569 LEUPROLIDE ACETATE KIT [MEITHEAL PHARMACEUTICALS INC] 1 Current NDC, 4 package rows 20240515_d6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa584.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71288-350-91 71288035091 0.5 mL in 1 PACKET 0.5 ml Historical 71288-565-03 71288056503 2.8 mL in 1 VIAL, MULTI-DOSE 2.8 ml Historical 71288-569-90 71288056990 1 KIT in 1 CARTON (71288-569-90) * 1 VIAL, MULTI-DOSE in 1 CARTON (71288-565-03) / 2.8 mL in 1 VIAL, MULTI-DOSE * .5 mL in 1 PACKET (71288-350-91) 1 kit 2024-05-15 No No Current