Home NDC 55566-1010 Fyremadel
Product NDC 55566-1010
11-digit product format 555661010
Labeler code 55566
Product ID 55566-1010_5b000831-15ef-44ff-9fce-3a2289d5e047
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ganirelix acetate
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Ferring Pharmaceuticals Inc.
Application ANDA204246
Marketing category ANDA
Marketing start 2022-02-28
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 A204246-001 FYREMADEL GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204246-001 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 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204246-001 GANIRELIX ACETATE 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204246-001 FYREMADEL 250MCG/0.5ML INJECTABLE / INJECTION AP 2018-11-30 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 Fyremadel
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855200 Internal RxNorm lookup 2587594 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 55566-1010-1 Fyremadel 1 in 1 CARTON INJECTION, SOLUTION 1 4 55566-1010-1 Fyremadel 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55566-1010 FYREMADEL (GANIRELIX ACETATE) INJECTION, SOLUTION [FERRING PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250109_5f0908b5-3551-47fd-95f7-3669b0dff7f1.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 55566-1010-1 55566101001 1 BLISTER PACK in 1 CARTON (55566-1010-1) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE 1 blister pack 2022-02-28 0000-00-00 No No Current