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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022201-001FIRMAGONDEGARELIX ACETATEEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-24
N022201-002FIRMAGONDEGARELIX ACETATEEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-24

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022201-001107297392029-02-10U-19782020-08-07
N022201-001109738702029-02-10U-19782021-04-13
N022201-00195793592029-02-10U-19782017-03-30
N022201-001125148982029-02-20U-19782026-01-27
N022201-001125333872029-02-20U-44172026-02-25
N022201-001106953982032-04-27U-18952020-07-07
N022201-001117664682032-04-27U-19782023-10-26
N022201-001118263972032-04-27U-19782023-12-15
N022201-00194150852032-04-27U-18952016-09-15
N022201-002107297392029-02-10U-19782020-08-07
N022201-002109738702029-02-10U-19782021-04-13
N022201-00295793592029-02-10U-19782017-03-30
N022201-002125148982029-02-20U-19782026-01-27
N022201-002125333872029-02-20U-44172026-02-25
N022201-002106953982032-04-27U-18952020-07-07
N022201-002117664682032-04-27U-19782023-10-26
N022201-002118263972032-04-27U-19782023-12-15
N022201-00294150852032-04-27U-18952016-09-15

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-24caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022201-001FIRMAGONEQ 80MG BASE/VIALPOWDER / SUBCUTANEOUSRLD2008-12-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022201-002FIRMAGONEQ 120MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2008-12-24bb7c543d1eb4…

Observed Orange Book patent history#

Patent history page 1 of 13 · 492 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N022201-001107297392029-02-10U-19782020-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-001109738702029-02-10U-19782021-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-00195793592029-02-10U-19782017-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-001125148982029-02-20U-19782026-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-001125333872029-02-20U-44172026-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-001106953982032-04-27U-18952020-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-001117664682032-04-27U-19782023-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-001118263972032-04-27U-19782023-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-00194150852032-04-27U-18952016-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-002107297392029-02-10U-19782020-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-002109738702029-02-10U-19782021-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-00295793592029-02-10U-19782017-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-002125148982029-02-20U-19782026-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-002125333872029-02-20U-44172026-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-002106953982032-04-27U-18952020-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-002117664682032-04-27U-19782023-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-002118263972032-04-27U-19782023-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07N022201-00294150852032-04-27U-18952016-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022201-001107297392029-02-10U-19782020-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-001109738702029-02-10U-19782021-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-00195793592029-02-10U-19782017-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-001125148982029-02-20U-19782026-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-001106953982032-04-27U-18952020-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-001117664682032-04-27U-19782023-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-001118263972032-04-27U-19782023-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-00194150852032-04-27U-18952016-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-002107297392029-02-10U-19782020-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-002109738702029-02-10U-19782021-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-00295793592029-02-10U-19782017-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-002125148982029-02-20U-19782026-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-002106953982032-04-27U-18952020-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-002117664682032-04-27U-19782023-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-002118263972032-04-27U-19782023-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022201-00294150852032-04-27U-18952016-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022201-001107297392029-02-10U-19782020-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022201-001109738702029-02-10U-19782021-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022201-00195793592029-02-10U-19782017-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022201-001106953982032-04-27U-18952020-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022201-001117664682032-04-27U-19782023-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022201-001118263972032-04-27U-19782023-12-1531067a03dcf5…

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828749Internal RxNorm lookup
828751Internal RxNorm lookup
858125Internal RxNorm lookup
858127Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab11dd8a-0fd9-4013-89ab-e114557c7e4bAvailable on FDA.report

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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIRMAGONDEGARELIXFerring Pharmaceuticals Inc.ab11dd8a-0fd9-4013-89ab-e114557c7e4b2024-01-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 022201
application number: NDA022201
ndc (product): 55566-8403

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