FDA.reportPublic FDA data

insulin, regular, human 12 UNT Inhalation Powder [Afrezza]

RxCUI
1654912
RxNorm name
insulin, regular, human 12 UNT Inhalation Powder [Afrezza]
Display name
insulin, regular, human 12 UNT Inhalation Powder [Afrezza]
Full name
insulin, regular, human 12 UNT Inhalation Powder [Afrezza]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:51

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
022472Afrezzainsulin human351(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
AFREZZAINSULIN HUMANMannkind Corporation29f4637b-e204-425b-b89c-7238008d8c102026-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1654912

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
29f4637b-e204-425b-b89c-7238008d8c10afrezza 12 UNT Inhalation Powder [PSN] · insulin, regular, human 12 UNT Inhalation Powder [Afrezza] [SBD] · Afrezza 12 UNT Inhalation Powder [SY]316These highlights do not include all the information needed to use AFREZZA ® safely and effectively. See full prescribing information for AFREZZA. AFREZZA ® (insulin human) inhalation powder, for oral inhalation use Initial U.S. Approval: 201420260203