Alferon

Product NDC
54746-001
Requested package NDC
54746-001-01
11-digit product format
547460001
Labeler code
54746
Product ID
54746-001_cf6f0c3b-a2f9-5aff-e053-2995a90a7045
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
interferon alfa-n3
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
AIM ImmunoTech Inc
Application
BLA103158
Marketing category
BLA
Marketing start
1989-10-10
Marketing end
0000-00-00
Substance
INTERFERON ALFA-N3
Active strength
5000000 [arb'U]/mL
Pharmacologic classes
Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54746-00154746-001-01IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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 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

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

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)Disc2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598014Alferon N 5,000,000 UNT/ML Injectable SolutionPSN241ece31-e649-021a-e054-00144ff8d46c8
615136interferon alpha-n3 5,000,000 UNT/ML Injectable SolutionPSN241ece31-e649-021a-e054-00144ff8d46c8
598014interferon alfa-n3 5000000 UNT/ML Injectable Solution [Alferon N]SBD241ece31-e649-021a-e054-00144ff8d46c8
615136interferon alfa-n3 5000000 UNT/ML Injectable SolutionSCD241ece31-e649-021a-e054-00144ff8d46c8
598014Alferon N 5,000,000 UNT/ML Injectable SolutionSY241ece31-e649-021a-e054-00144ff8d46c8
615136interferon alpha-n3 5,000,000 UNT/ML Injectable SolutionSY241ece31-e649-021a-e054-00144ff8d46c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54746-001-01547460001010 mL in 1 VIAL, GLASS (54746-001-01) 0 ml1989-10-100000-00-00NoNoCurrent