FDA.reportPublic FDA data

alpha 1-proteinase inhibitor, human 1 MG Injection

RxCUI
1661208
RxNorm name
alpha 1-proteinase inhibitor, human 1 MG Injection
Display name
alpha 1-proteinase inhibitor, human 1 MG Injection
Full name
alpha 1-proteinase inhibitor, human 1 MG Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125078ZemairaAlpha-1-Proteinase Inhibitor (Human)351(a)Rx2026-09-01
103174prolastin,prolastin-c,prolastin-c liquidAlpha-1-Proteinase Inhibitor (Human)351(a)Rx2026-09-01
125039Aralast, Aralast NpAlpha-1-Proteinase Inhibitor (Human)351(a)Rx2026-09-01
125325GlassiaAlpha-1-Proteinase Inhibitor (Human)351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
83473cbb-48e4-42a2-81b6-4c851423da7balpha 1-proteinase inhibitor, human 1 MG Injection [PSN] · alpha 1-proteinase inhibitor, human 1 MG Injection [SCD]231These highlights do not include all the information needed to use GLASSIA safely and effectively. See full prescribing information for GLASSIA. GLASSIA ® (Alpha 1 -Proteinase Inhibitor (Human)) Injection, For Intravenous Use Initial U.S. Approval: 201020251202
0c3354b5-a1d8-4f98-ad55-2eafe4265c4ealpha 1-proteinase inhibitor, human 1 MG Injection [PSN] · alpha 1-proteinase inhibitor, human 1 MG Injection [SCD]227These highlights do not include all the information needed to use ZEMAIRA safely and effectively. See full prescribing information for ZEMAIRA. ZEMAIRA ® (alpha 1 -proteinase inhibitor (human)) lyophilized powder for reconstitution for intravenous use Initial U.S. Approval: 200320240923
91edab72-c889-470e-8315-1798b5548dcaalpha 1-proteinase inhibitor, human 1 MG Injection [PSN] · alpha 1-proteinase inhibitor, human 1 MG Injection [SCD]225These highlights do not include all the information needed to use PROLASTIN ® -C safely and effectively. See full prescribing information for PROLASTIN-C. PROLASTIN ® -C (Alpha 1 -Proteinase Inhibitor [Human]) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 198720220225
a9a5b46e-04da-41bd-bb5f-c4936b664fefalpha 1-proteinase inhibitor, human 1 MG Injection [PSN] · alpha 1-proteinase inhibitor, human 1 MG Injection [SCD]220These highlights do not include all the information needed to use ARALAST NP safely and effectively. See full prescribing information for ARALAST NP. ARALAST ® NP (Alpha 1 -Proteinase Inhibitor (Human)) For Intravenous Use. Lyophilized Powder for Solution for Injection Initial U.S. Approval: 200220251125
2b620e6b-6a24-0957-1288-ae529c4cc3a2alpha 1-proteinase inhibitor, human 1 MG Injection [PSN] · alpha 1-proteinase inhibitor, human 1 MG Injection [SCD]214These highlights do not include all the information needed to use PROLASTIN-C LIQUID safely and effectively. See full prescribing information for PROLASTIN-C LIQUID. PROLASTIN-C LIQUID (Alpha 1 -Proteinase Inhibitor [Human]) Solution for Intravenous Injection Initial U.S. Approval: 198720220705
31a53b86-857b-a2d9-e063-6394a90abfb8alpha 1-proteinase inhibitor, human 1 MG Injection [PSN] · alpha 1-proteinase inhibitor, human 1 MG Injection [SCD]2120250331