Home NDC 78206-138 Ganirelix Acetate
Product NDC 78206-138
11-digit product format 782060138
Labeler code 78206
Product ID 78206-138_8e2e2cd7-1d83-4f9f-85be-d047bf413f98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ganirelix Acetate
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Organon LLC
Application NDA021057
Marketing category NDA
Marketing start 2021-06-01
Substance GANIRELIX ACETATE
Active strength 250 ug/.5mL
Pharmacologic classes Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Ganirelix Acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GANIRELIX ACETATE 250 ug/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 56U7906FQW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855200 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 78206-138-01 Ganirelix Acetate 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 8 78206-138-01 Ganirelix Acetate 1 in 1 CARTON INJECTION, SOLUTION 1 8 78206-138-02 Ganirelix Acetate 1 in 1 CARTON INJECTION, SOLUTION 1 8 78206-138-02 Ganirelix Acetate 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-138 GANIRELIX ACETATE INJECTION, SOLUTION [ORGANON LLC] 7 Current NDC, Legacy NDC, 4 package rows 20240228_32fb74ff-993a-49fe-8943-e029372b863e.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 78206-138-01 78206013801 1 BLISTER PACK in 1 CARTON (78206-138-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS 1 blister pack 2021-06-01 0000-00-00 No No Current 78206-138-02 78206013802 1 BLISTER PACK in 1 CARTON (78206-138-02) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS 1 blister pack 2024-02-16 No No Current