FDA.reportPublic FDA data

Gonal-f

Product NDC
44087-9030
11-digit product format
440879030
Labeler code
44087
Product ID
44087-9030_cce3fe26-e11c-4cc9-9cf9-5841913db5ba
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
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui351125, 351993

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
44087-9030-1Gonal-f1 in 1 CARTONKIT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-9030-1EA - Each44087-90302c37305a-a548-4139-827b-e30d66ea063412012-07-24

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
44087-9030GONAL-F (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.]13Current NDC, Legacy NDC, 1 package rows20240727_ae85b9c3-e7eb-4981-a5d9-346050e8f189.zip

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
44087-9030-1440879030011 KIT in 1 CARTON (44087-9030-1) * 1 mL in 1 VIAL * 1 mL in 1 SYRINGE1 kit2004-03-250000-00-00NoNoCurrent