FDA.reportPublic FDA data

FIRMAGON

Product NDC
55566-8403
11-digit product format
555668403
Labeler code
55566
Product ID
55566-8403_4c6e7e6f-aadd-45b1-baed-970b24766bf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Degarelix
Dosage form
KIT
Labeler
Ferring Pharmaceuticals Inc.
Application
NDA022201
Marketing category
NDA
Marketing start
2009-03-02
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui828749, 828751, 858125, 858127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9a9dba49-8fcc-425e-97ab-178dbd2451b7Product name120230822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55566-8403-12024-01-31C16284748780-11030e365-016f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FIRMAGON safely and effectively. See full prescribing information for FIRMAGON. FIRMAGON ® (degarelix for injection) for subcutaneous use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55566-8403-1FIRMAGON1 in 1 CARTONKIT118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55566-8403-1EA - Each55566-8403b1f8d24c-68a5-49c5-8080-00f4ef32753312013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DegarelixACTIVE INGREDIENTSX0XJI3A11FIRMAGON (DEGARELIX) KIT [FERRING PHARMACEUTICALS INC.]6
DegarelixACTIVE MOIETYSX0XJI3A11FIRMAGON (DEGARELIX) KIT [FERRING PHARMACEUTICALS INC.]6
MannitolINACTIVE INGREDIENT3OWL53L36AFIRMAGON (DEGARELIX) KIT [FERRING PHARMACEUTICALS INC.]6
WaterINACTIVE INGREDIENT059QF0KO0RFIRMAGON (DEGARELIX) KIT [FERRING PHARMACEUTICALS INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55566-8403FIRMAGON (DEGARELIX) KIT [FERRING PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 1 package rows20240201_ab11dd8a-0fd9-4013-89ab-e114557c7e4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828751degarelix 120 MG InjectionPSNab11dd8a-0fd9-4013-89ab-e114557c7e4b18
828749degarelix 80 MG InjectionPSNab11dd8a-0fd9-4013-89ab-e114557c7e4b18
858127FIRMAGON 120 MG InjectionPSNab11dd8a-0fd9-4013-89ab-e114557c7e4b18
858125FIRMAGON 80 MG InjectionPSNab11dd8a-0fd9-4013-89ab-e114557c7e4b18
858127degarelix 120 MG Injection [Firmagon]SBDab11dd8a-0fd9-4013-89ab-e114557c7e4b18
858125degarelix 80 MG Injection [Firmagon]SBDab11dd8a-0fd9-4013-89ab-e114557c7e4b18
828751degarelix 120 MG InjectionSCDab11dd8a-0fd9-4013-89ab-e114557c7e4b18
828749degarelix 80 MG InjectionSCDab11dd8a-0fd9-4013-89ab-e114557c7e4b18
828751degarelix (as degarelix acetate) 120 MG InjectionSYab11dd8a-0fd9-4013-89ab-e114557c7e4b18
828749degarelix (as degarelix acetate) 80 MG InjectionSYab11dd8a-0fd9-4013-89ab-e114557c7e4b18
858127Firmagon 120 MG InjectionSYab11dd8a-0fd9-4013-89ab-e114557c7e4b18
858125Firmagon 80 MG InjectionSYab11dd8a-0fd9-4013-89ab-e114557c7e4b18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55566-8403-1555668403011 KIT in 1 CARTON (55566-8403-1) * 3 mL in 1 SYRINGE * 3 mL in 1 VIAL, GLASS1 kit2009-03-020000-00-00NoNoCurrent