Home NDC 72664-611 Leuprolide Acetate
Product NDC 72664-611
11-digit product format 726640611
Labeler code 72664
Product ID 72664-611_441a43d5-2a8c-2d53-e063-6294a90a385d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Leuprolide Acetate
Dosage form KIT
Labeler VGYAAN Pharmaceuticals LLC
Application ANDA213829
Marketing category ANDA
Marketing start 2020-10-25
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 A213829-001 LEUPROLIDE ACETATE LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213829-001 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.
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 A213829-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213829-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213829-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213829-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213829-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213829-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213829-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213829-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213829-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213829-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213829-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213829-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2021-08-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213829-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2021-08-13 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Leuprolide Acetate
Listing expiration 2026-12-31 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 72664-611-28 Leuprolide Acetate 1 in 1 CARTON KIT 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72664-611 LEUPROLIDE ACETATE KIT [VGYAAN PHARMACEUTICALS LLC] 6 Current NDC, Legacy NDC, 1 package rows 20250110_bec9077a-3f04-4887-856d-dde2de24584d.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72664-611-28 72664061128 1 KIT in 1 CARTON (72664-611-28) * 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET 1 kit 2020-10-25 0000-00-00 No No Current