Home NDC 47335-936 leuprolide acetate
Product NDC 47335-936
11-digit product format 473350936
Labeler code 47335
Product ID 47335-936_ebfec8b9-a556-4304-af58-2c305db723af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name leuprolide acetate
Dosage form KIT
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA078885
Marketing category ANDA
Marketing start 2014-12-15
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078885-001 LEUPROLIDE ACETATE LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2009-03-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078885-001 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 A078885-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2009-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078885-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2009-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078885-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2009-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078885-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2009-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078885-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2009-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078885-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2009-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078885-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2009-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078885-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2009-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078885-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2009-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078885-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2009-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078885-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2009-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078885-001 LEUPROLIDE ACETATE 1MG/0.2ML INJECTABLE / INJECTION AP 2009-03-09 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 47335-936-40 leuprolide acetate 1 in 1 CARTON KIT 1 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-936 LEUPROLIDE ACETATE KIT [SUN PHARMACEUTICAL INDUSTRIES, INC.] 15 Current NDC, Legacy NDC, 1 package rows 20241127_a3b01473-30c7-4945-bd60-2484221aaaad.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 Marketing end Sample Exclude flag Status 47335-936-40 47335093640 1 KIT in 1 CARTON (47335-936-40) * 1 VIAL, MULTI-DOSE in 1 CARTON / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET 1 kit 2014-12-15 0000-00-00 No No Current