FDA.reportPublic FDA data

follitropin alfa 600 UNT/ML Injectable Solution [Gonal F]

RxCUI
351993
RxNorm name
follitropin alfa 600 UNT/ML Injectable Solution [Gonal F]
Display name
follitropin alfa 600 UNT/ML Injectable Solution [Gonal F]
Full name
follitropin alfa 600 UNT/ML Injectable Solution [Gonal F]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:15

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020378Gonal-ffollitropin alfa351(a)Disc2026-08-01

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-fFOLLITROPIN ALFAEMD Serono, Inc.ae85b9c3-e7eb-4981-a5d9-346050e8f1892025-09-02Warnings, Adverse reactionsExact identifier
rxcui: 351993

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
ae85b9c3-e7eb-4981-a5d9-346050e8f189GONAL-f 600 UNT/ML Injectable Solution [PSN] · follitropin alfa 600 UNT/ML Injectable Solution [Gonal F] [SBD] · Gonal F 600 UNT/ML Injectable Solution [SY]315These highlights do not include all the information needed to use GONAL-f ® safely and effectively. See full prescribing information for GONAL-f ® GONAL-f ® (follitropin alfa) for injection, for subcutaneous use Initial U.S. Approval: 199720250902