FDA.reportPublic FDA data

Myalept 11.3 MG per 2.2 ML Injectable Solution

RxCUI
1491634
RxNorm name
Myalept 11.3 MG per 2.2 ML Injectable Solution
Display name
Myalept 11.3 MG per 2.2 ML Injectable Solution
Full name
Myalept 11.3 MG per 2.2 ML Injectable Solution
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125390Myaleptmetreleptin351(a)Rx2026-08-01

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
MyaleptMETRELEPTINChiesi USA, Inc.d3b50bbd-140b-425c-b5ec-d4682aad62bc2024-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1491634

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
d3b50bbd-140b-425c-b5ec-d4682aad62bcmyalept 5 MG/ML Injectable Solution [PSN] · metreleptin 5 MG/ML Injectable Solution [Myalept] [SBD] · Myalept 11.3 MG per 2.2 ML Injectable Solution [SY] · Myalept 5 MG/ML Injectable Solution [SY]418These highlights do not include all the information needed to use MYALEPT safely and effectively. See full prescribing information for MYALEPT. MYALEPT ® (metreleptin) for injection, for subcutaneous use Initial U.S. Approval: 201420240325