FDA.reportPublic FDA data

somatropin 0.8 MG per 0.25 ML Prefilled Syringe

RxCUI
762841
RxNorm name
somatropin 0.8 MG per 0.25 ML Prefilled Syringe
Display name
somatropin 0.8 MG per 0.25 ML Prefilled Syringe
Full name
somatropin 0.8 MG per 0.25 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:30

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020280Genotropinsomatropin351(a)Disc2026-07-01

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
GENOTROPINSOMATROPINPfizer Laboratories Div Pfizer Incffebf88b-d257-4542-9808-74d9b71677652026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 762841

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
ffebf88b-d257-4542-9808-74d9b7167765somatropin 0.8 MG in 0.25 ML Prefilled Syringe [PSN] · 0.25 ML somatropin 3.2 MG/ML Prefilled Syringe [SCD] · somatropin 0.8 MG per 0.25 ML Prefilled Syringe [SY]336These highlights do not include all the information needed to use GENOTROPIN safely and effectively. See full prescribing information for GENOTROPIN GENOTROPIN ® (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 198720260430