FDA.reportPublic FDA data

ZEMAIRA

Manufacturer
Fisher Clinical Services Inc. | Fisher Clinical Services
Effective date
2025-03-31
Label type
PLASMA DERIVATIVE
Version
1
Source
full-release
Hydrated at
2026-06-01 02:51:33

Label at a glance#

ProductZEMAIRA
Active ingredient.ALPHA.1-PROTEINASE INHIBITOR HUMAN
Label structure3 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zemaira 1000mg cartonZemaira 1000mg carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zemaira 4000mgZemaira 4000mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zemaira 500mgZemaira 500mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1661208alpha 1-proteinase inhibitor, human 1 MG InjectionPSN1
991722Zemaira 1 MG InjectionPSN1
991722alpha 1-proteinase inhibitor, human 1 MG Injection [Zemaira]SBD1
1661208alpha 1-proteinase inhibitor, human 1 MG InjectionSCD1
991722Zemaira 1 MG InjectionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
.ALPHA.1-PROTEINASE INHIBITOR HUMAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57516-101-02ZEMAIRA1 in 1 CARTONKIT11
57516-102-01ZEMAIRA20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,20 mL1000 mg in 20mL1
57516-110-02ZEMAIRA1 in 1 CARTONKIT11
57516-111-01ZEMAIRA76 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,76 mL4000 mg in 76mL1
57516-113-02ZEMAIRA1 in 1 CARTONKIT11
57516-114-01ZEMAIRA95 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,95 mL5000 mg in 95mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57516-101ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN KIT) KIT [FISHER CLINICAL SERVICES INC.]1Current NDC, 2 package rows20250403_31a53b86-857b-a2d9-e063-6394a90abfb8.zip
57516-102ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN KIT) KIT [FISHER CLINICAL SERVICES INC.]1Unmatched20250403_31a53b86-857b-a2d9-e063-6394a90abfb8.zip
57516-103ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN KIT) KIT [FISHER CLINICAL SERVICES INC.]1Unmatched20250403_31a53b86-857b-a2d9-e063-6394a90abfb8.zip
57516-110ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN KIT) KIT [FISHER CLINICAL SERVICES INC.]1Current NDC, 2 package rows20250403_31a53b86-857b-a2d9-e063-6394a90abfb8.zip
57516-111ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN KIT) KIT [FISHER CLINICAL SERVICES INC.]1Unmatched20250403_31a53b86-857b-a2d9-e063-6394a90abfb8.zip
57516-112ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN KIT) KIT [FISHER CLINICAL SERVICES INC.]1Unmatched20250403_31a53b86-857b-a2d9-e063-6394a90abfb8.zip
57516-113ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN KIT) KIT [FISHER CLINICAL SERVICES INC.]1Current NDC, 2 package rows20250403_31a53b86-857b-a2d9-e063-6394a90abfb8.zip
57516-114ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN KIT) KIT [FISHER CLINICAL SERVICES INC.]1Unmatched20250403_31a53b86-857b-a2d9-e063-6394a90abfb8.zip
57516-115ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN KIT) KIT [FISHER CLINICAL SERVICES INC.]1Unmatched20250403_31a53b86-857b-a2d9-e063-6394a90abfb8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57516-10157516-101-02
57516-11057516-110-02
57516-11357516-113-02
57516-11457516-114-01
57516-11557516-115-20
57516-11157516-111-01
57516-11257516-112-20
57516-10257516-102-01
57516-10357516-103-20

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

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
MANNITOL3OWL53L36AIACT
.ALPHA.1-PROTEINASE INHIBITOR HUMANF43I396OISACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROCHLORIC ACIDQTT17582CBIACT
WATER059QF0KO0RIACT
MANNITOL3OWL53L36AIACT
.ALPHA.1-PROTEINASE INHIBITOR HUMANF43I396OISACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROCHLORIC ACIDQTT17582CBIACT
WATER059QF0KO0RIACT
MANNITOL3OWL53L36AIACT
SODIUM PHOSPHATESE337SVY37IACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
.ALPHA.1-PROTEINASE INHIBITOR HUMANF43I396OISACTIB
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aridol Bronchial Challenge Test KitMANNITOLMethapharm, Inc.5387a4fb-b894-4cba-88a3-a947217d34da2026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsName fallback
generic name: MANNITOL
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsName fallback
generic name: MANNITOL

Reported adverse events (FAERS/openFDA)#

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