FDA.reportPublic FDA data

Gonal-f

Product NDC
44087-9070
11-digit product format
440879070
Labeler code
44087
Product ID
44087-9070_79bd5a3e-40ae-4710-9104-d54cc4683716
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
follitropin alfa
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
EMD Serono, Inc.
Application
BLA020378
Marketing category
BLA
Marketing start
2004-03-25
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct44087-9070DDiscontinued by firm2026-08-07
excluded packagepackage44087-907044087-9070-1DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct44087-9070DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage44087-907044087-9070-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19306eca-07d9-869e-c7a4-1581f31ccc9aProduct name220200323
568cb8c1-4b4c-2263-a98f-4f62151e332fProduct name220200323
79651c92-221b-ba7b-52e2-f902ea49889dProduct name220200323
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-9070-1Gonal-f1 in 1 CARTONKIT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-9070-1EA - Each44087-9070281263db-0925-425e-a01a-ced84ddcb41d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOLLITROPINACTIVE INGREDIENT076WHW89TWGONAL-F (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.]4
FOLLITROPINACTIVE MOIETY076WHW89TWGONAL-F (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHGONAL-F (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.]4
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNGONAL-F (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGONAL-F (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.]4
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TGONAL-F (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.]4
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNGONAL-F (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554GONAL-F (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RGONAL-F (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44087-9070GONAL-F (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.]13Legacy NDC, 1 package rows20240727_ae85b9c3-e7eb-4981-a5d9-346050e8f189.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
Gonal-fFOLLITROPIN ALFAEMD Serono, Inc.ae85b9c3-e7eb-4981-a5d9-346050e8f1892025-09-02Warnings, Adverse reactionsExact identifier
application number: BLA020378
ndc (product): 44087-9070

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020378Gonal-ffollitropin alfa351(a)Disc2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351125follitropin alfa 600 UNT/ML Injectable SolutionPSNae85b9c3-e7eb-4981-a5d9-346050e8f18915
351993GONAL-f 600 UNT/ML Injectable SolutionPSNae85b9c3-e7eb-4981-a5d9-346050e8f18915
351993follitropin alfa 600 UNT/ML Injectable Solution [Gonal F]SBDae85b9c3-e7eb-4981-a5d9-346050e8f18915
351125follitropin alfa 600 UNT/ML Injectable SolutionSCDae85b9c3-e7eb-4981-a5d9-346050e8f18915
351993Gonal F 600 UNT/ML Injectable SolutionSYae85b9c3-e7eb-4981-a5d9-346050e8f18915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44087-9070-1440879070011 KIT in 1 CARTON (44087-9070-1) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE1 kit2004-03-250000-00-00NoNoCurrent