FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Fyremadel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GANIRELIX ACETATE250 ug/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56U7906FQW
Rxcui855200, 2587594

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1a687bc4-8d90-54b3-7bbb-399cd21f76f1Product name520260209
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55566-1010-1Fyremadel1 in 1 CARTONINJECTION, SOLUTION14
55566-1010-1Fyremadel1 in 1 BLISTER PACKINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55566-1010-1ML - Milliliter55566-10107ff59245-8d74-45c3-bda5-b0de166fa1c312022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55566-1010FYREMADEL (GANIRELIX ACETATE) INJECTION, SOLUTION [FERRING PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20250109_5f0908b5-3551-47fd-95f7-3669b0dff7f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2587594Fyremadel 250 MCG in 0.5 ML Prefilled SyringePSN5f0908b5-3551-47fd-95f7-3669b0dff7f14
855200ganirelix acetate 250 MCG in 0.5 ML Prefilled SyringePSN5f0908b5-3551-47fd-95f7-3669b0dff7f14
25875940.5 ML ganirelix acetate 0.5 MG/ML Prefilled Syringe [Fyremadel]SBD5f0908b5-3551-47fd-95f7-3669b0dff7f14
8552000.5 ML ganirelix acetate 0.5 MG/ML Prefilled SyringeSCD5f0908b5-3551-47fd-95f7-3669b0dff7f14
25875940.5 ML Fyremadel 0.5 MG/ML Prefilled SyringeSY5f0908b5-3551-47fd-95f7-3669b0dff7f14
2587594Fyremadel 250 MCG per 0.5 ML Prefilled SyringeSY5f0908b5-3551-47fd-95f7-3669b0dff7f14
855200ganirelix acetate 0.5 MG/ML 0.5 ML Prefilled SyringeSY5f0908b5-3551-47fd-95f7-3669b0dff7f14
855200ganirelix acetate 250 MCG per 0.5 ML Prefilled SyringeSY5f0908b5-3551-47fd-95f7-3669b0dff7f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55566-1010-1555661010011 BLISTER PACK in 1 CARTON (55566-1010-1) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE1 blister pack2022-02-280000-00-00NoNoCurrent