FDA.reportPublic FDA data

follitropin alfa 900 UNT in 1.44 ML Pen Injector

RxCUI
1654184
RxNorm name
follitropin alfa 900 UNT in 1.44 ML Pen Injector
Display name
follitropin alfa 900 UNT in 1.44 ML Pen Injector
Full name
follitropin alfa 900 UNT in 1.44 ML Pen Injector
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021684Gonal-f RFF RediJectfollitropin alfa351(a)Rx2026-07-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.b6d11c45-b502-478e-bb28-2ff596ea259c2025-04-03Warnings, Adverse reactionsExact identifier
rxcui: 1654184

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b6d11c45-b502-478e-bb28-2ff596ea259cfollitropin alfa 900 UNT in 1.44 ML Pen Injector [PSN] · 1.44 ML follitropin alfa 625 UNT/ML Pen Injector [SCD] · follitropin alfa 900 UNT per 1.44 ML Pen Injector [SY]313These 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: 199720250403