FDA.reportPublic FDA data

Gonal-f RFF Redi-ject

Product NDC
44087-1115
11-digit product format
440871115
Labeler code
44087
Product ID
44087-1115_657d712c-ea55-4e2b-9111-ed8dc792887b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FOLLITROPIN
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
EMD Serono, Inc.
Application
BLA021684
Marketing category
BLA
Marketing start
2013-10-16
Substance
FOLLITROPIN
Active strength
300 [iU]/.5mL
Pharmacologic classes
Gonadotropin [EPC], Gonadotropins [CS]
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 RFF Redi-ject
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOLLITROPIN300 [iU]/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii076WHW89TW
Rxcui1594334, 1594418, 1594432, 1654171, 1654179, 1654184

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44087-1115-12022-02-02C16284748780-1d6a99b39-a56a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use GONAL-f ® RFF Redi-ject ® safely and effectively. See full prescribing information for GONAL-f ® RFF Redi-ject ® GONAL-f ® RFF Redi-ject ® (follitropin alfa) injection for subcutaneous use Initial U.S. Approval: 1997
44087-1115-12022-01-28C16284748780-1d6a99b39-a56a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use GONAL-f ® RFF Redi-ject ® safely and effectively. See full prescribing information for GONAL-f ® RFF Redi-ject ® GONAL-f ® RFF Redi-ject ® (follitropin alfa) injection for subcutaneous use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-1115-1Gonal-f RFF Redi-ject1 in 1 CARTONINJECTION, SOLUTION113
44087-1115-1Gonal-f RFF Redi-ject0.5 mL in 1 PACKAGEINJECTION, SOLUTION0.513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-1115-1ML - Milliliter44087-1115d9867994-433e-4d5c-b166-febe59c660d512014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOLLITROPINACTIVE INGREDIENT076WHW89TWGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
FOLLITROPINACTIVE MOIETY076WHW89TWGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
METACRESOLINACTIVE INGREDIENTGGO4Y809LOGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
METHIONINEINACTIVE INGREDIENTAE28F7PNPLGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44087-1115GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]13Current NDC, Legacy NDC, 2 package rows20250406_b6d11c45-b502-478e-bb28-2ff596ea259c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654171follitropin alfa 300 UNT in 0.48 ML Pen InjectorPSNb6d11c45-b502-478e-bb28-2ff596ea259c13
1654179follitropin alfa 450 UNT in 0.72 ML Pen InjectorPSNb6d11c45-b502-478e-bb28-2ff596ea259c13
1654184follitropin alfa 900 UNT in 1.44 ML Pen InjectorPSNb6d11c45-b502-478e-bb28-2ff596ea259c13
1594432GONAL-f RFF Pen 300 UNT in 0.48 ML Pen InjectorPSNb6d11c45-b502-478e-bb28-2ff596ea259c13
1594418GONAL-f RFF Pen 450 UNT in 0.72 ML Pen InjectorPSNb6d11c45-b502-478e-bb28-2ff596ea259c13
1594334GONAL-f RFF Pen 900 UNT in 1.44 ML Pen InjectorPSNb6d11c45-b502-478e-bb28-2ff596ea259c13
15944320.48 ML follitropin alfa 625 UNT/ML Pen Injector [Gonal F]SBDb6d11c45-b502-478e-bb28-2ff596ea259c13
15944180.72 ML follitropin alfa 625 UNT/ML Pen Injector [Gonal F]SBDb6d11c45-b502-478e-bb28-2ff596ea259c13
15943341.44 ML follitropin alfa 625 UNT/ML Pen Injector [Gonal F]SBDb6d11c45-b502-478e-bb28-2ff596ea259c13
16541710.48 ML follitropin alfa 625 UNT/ML Pen InjectorSCDb6d11c45-b502-478e-bb28-2ff596ea259c13
16541790.72 ML follitropin alfa 625 UNT/ML Pen InjectorSCDb6d11c45-b502-478e-bb28-2ff596ea259c13
16541841.44 ML follitropin alfa 625 UNT/ML Pen InjectorSCDb6d11c45-b502-478e-bb28-2ff596ea259c13
15944320.48 ML Gonal F 625 UNT/ML Pen InjectorSYb6d11c45-b502-478e-bb28-2ff596ea259c13
15944180.72 ML Gonal F 625 UNT/ML Pen InjectorSYb6d11c45-b502-478e-bb28-2ff596ea259c13
15943341.44 ML Gonal F 625 UNT/ML Pen InjectorSYb6d11c45-b502-478e-bb28-2ff596ea259c13
1654171follitropin alfa 300 UNT per 0.48 ML Pen InjectorSYb6d11c45-b502-478e-bb28-2ff596ea259c13
1654179follitropin alfa 450 UNT per 0.72 ML Pen InjectorSYb6d11c45-b502-478e-bb28-2ff596ea259c13
1654184follitropin alfa 900 UNT per 1.44 ML Pen InjectorSYb6d11c45-b502-478e-bb28-2ff596ea259c13
1594418Gonal F 450 UNT per 0.72 ML Pen InjectorSYb6d11c45-b502-478e-bb28-2ff596ea259c13
1594432Gonal F RFF 300 UNT per 0.48 ML Pen InjectorSYb6d11c45-b502-478e-bb28-2ff596ea259c13
1594334Gonal F RFF Pen 900 UNT per 1.44 ML Pen InjectorSYb6d11c45-b502-478e-bb28-2ff596ea259c13
1594432Gonal F RFF Redi-ject 300 UNT per 0.48 ML Pen InjectorSYb6d11c45-b502-478e-bb28-2ff596ea259c13
1594418Gonal F RFF Redi-ject 450 UNT per 0.72 ML Pen InjectorSYb6d11c45-b502-478e-bb28-2ff596ea259c13
1594334Gonal F RFF Redi-ject 900 UNT per 1.44 ML Pen InjectorSYb6d11c45-b502-478e-bb28-2ff596ea259c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44087-1115-1440871115011 PACKAGE in 1 CARTON (44087-1115-1) / .5 mL in 1 PACKAGE1 package2013-10-160000-00-00NoNoCurrent