FDA.reportPublic FDA data

ZOMACTON 10 MG/ML Injectable Solution

RxCUI
1648160
RxNorm name
ZOMACTON 10 MG/ML Injectable Solution
Display name
ZOMACTON 10 MG/ML Injectable Solution
Full name
ZOMACTON 10 MG/ML Injectable Solution
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
019774Zomactonsomatropin351(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
ZOMACTONSOMATROPINFerring Pharmaceuticals Inc.85ba081b-bee0-4a9a-aa0f-ae5b5e9a08862025-11-14Warnings, Adverse reactionsExact identifier
rxcui: 1648160

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
85ba081b-bee0-4a9a-aa0f-ae5b5e9a0886ZOMACTON 10 MG/ML Injectable Solution [PSN] · somatropin 10 MG/ML Injectable Solution [Zomacton] [SBD] · Zomacton 10 MG/ML Injectable Solution [SY]323These highlights do not include all the information needed to use ZOMACTON ® safely and effectively. See full prescribing information for ZOMACTON. ZOMACTON ® (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 199520260224