Home NDC 0052-0301-81 Ganirelix Acetate
Product NDC 0052-0301
Requested package NDC 0052-0301-81
11-digit product format 000520301
Labeler code 0052
Product ID 0052-0301_21680ef9-07e9-4350-8f1b-51232fc3f0e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ganirelix Acetate
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Organon USA Inc.
Application NDA021057
Marketing category NDA
Marketing start 1999-07-29
Marketing end 0000-00-00
Substance GANIRELIX ACETATE
Active strength 250 ug/.5mL
Pharmacologic classes Decreased GnRH Secretion [PE],Gonadotropin Releasing Hormone Antagonist [EPC],Gonadotropin Releasing Hormone Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N021057-001 GANIRELIX ACETATE GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021057-001 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 · 42 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 2026-08-18 06:07:40 2026-07 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021057-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP RLD, RS 1999-07-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0052-0301-81 00052030181 1 BLISTER PACK in 1 CARTON (0052-0301-81) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS 1 blister pack 1999-07-29 0000-00-00 No No Current