FDA.reportPublic FDA data

somatropin 5 MG/ML Injectable Solution [Omnitrope]

RxCUI
645884
RxNorm name
somatropin 5 MG/ML Injectable Solution [Omnitrope]
Display name
somatropin 5 MG/ML Injectable Solution [Omnitrope]
Full name
somatropin 5 MG/ML Injectable Solution [Omnitrope]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:59

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021426Omnitropesomatropin351(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
OmnitropeSOMATROPINSandoz Inc58d84ffa-4056-4e36-ad67-7bd4aef444a52025-07-10Warnings, Adverse reactionsExact identifier
rxcui: 645884

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
58d84ffa-4056-4e36-ad67-7bd4aef444a5Omnitrope 5 MG/ML Injectable Solution [PSN] · somatropin 5 MG/ML Injectable Solution [Omnitrope] [SBD] · Omnitrope 5 MG/ML Injectable Solution [SY]336These highlights do not include all the information needed to use OMNITROPE safely and effectively. See full prescribing information for OMNITROPE. OMNITROPE ® (somatropin) injection, for subcutaneous use OMNITROPE ® (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 198720250710