FDA.reportPublic FDA data

Alferon

Manufacturer
AIM ImmunoTech Inc | AIM ImmunoTech Inc.
Effective date
2021-10-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 20:38:11

Label at a glance#

ProductAlferon
Active ingredientINTERFERON ALFA-N3
Label structure3 sections

Storage and handling

STORAGE Alferon N Injection® [Interferon alfa-n3 (human leukocyte derived)] should be stored at 2º to 8ºC (36º to 46ºF). Do not Freeze. Do not shake.

Label contents#

Full prescribing information#

Storage

STORAGE AND HANDLING SECTION

STORAGE Alferon N Injection® [Interferon alfa-n3 (human leukocyte derived)] should be stored at 2º to 8ºC (36º to 46ºF). Do not Freeze. Do not shake.

carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton labelcarton label

vial label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

vial labelvial label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
598014Alferon N 5,000,000 UNT/ML Injectable SolutionPSN8
615136interferon alpha-n3 5,000,000 UNT/ML Injectable SolutionPSN8
598014interferon alfa-n3 5000000 UNT/ML Injectable Solution [Alferon N]SBD8
615136interferon alfa-n3 5000000 UNT/ML Injectable SolutionSCD8
598014Alferon N 5,000,000 UNT/ML Injectable SolutionSY8
615136interferon alpha-n3 5,000,000 UNT/ML Injectable SolutionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HUMAN LEUCOCYTE-DERIVED ALPHA INTERFERONS Pharmacologic Class Indexing1Indexing - Pharmacologic Class20110207

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54746-001-012023-01-30C16284748780-1f386c649-f41c-0266-e053-dadaa90a7c1a241ece31-e649-021a-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54746-001-01Alferon00 mL in 1 VIAL, GLASSINJECTION008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54746-001ALFERON (INTERFERON ALFA-N3) INJECTION [AIM IMMUNOTECH INC]8Legacy NDC, 1 package rows20211030_241ece31-e649-021a-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54746-001-01ML - Milliliter54746-001b5c5c051-0753-4da1-851f-5e7610ab778a12016-02-04

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54746-00154746-001-01

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103158Alferon N Injectioninterferon alfa-n3 (human leukocyte derived)351(a)Disc2026-09-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
INTERFERON ALFA-N347BPR3V3MPACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cf6f0c3b-a2f9-5aff-e053-2995a90a7045241ece31-e649-021a-e054-00144ff8d46c2021-10-28Exact identifier
spl id: cf6f0c3b-a2f9-5aff-e053-2995a90a7045
spl set id: 241ece31-e649-021a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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