OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

REBIF REBIDOSE

Interferon Beta-1A · Injection, Solution

Prescription BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
REBIF REBIDOSE
Generic name
Interferon Beta-1A
Dosage form
Injection, Solution
Route
Subcutaneous
Marketing category
BLA · BLA
Labeler
EMD Serono, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
46% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Interferon Beta-1A 22 ug/.5mL 758025 View
Interferon Beta-1A 44 ug/.5mL 758025 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Subcutaneous
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Interferon beta [EPC] EPC 3 members — no class page
Interferon-beta [CS] CS 3 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
103780
Application type
BLA · Biologics License Application
Approval date
March 7, 2002
Sponsor
SERONO INC
Products on application
2
Submissions recorded
18
Products approved under application 103780.
Product Trade name Form Strength Ingredient Status TE Flags
103780-001 REBIF SYRINGE INTERFERON BETA-1A Prescription —
103780-002 REBIF SYRINGE INTERFERON BETA-1A Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 103780.
Type No. Action Status Date Review
Supplement 5214 Labeling Approved July 28, 2023 Standard
Supplement 5210 Labeling Approved November 3, 2021 Standard
Supplement 5207 Labeling Approved May 26, 2020 Standard
Supplement 5203 Efficacy Approved May 26, 2020 Standard
Supplement 5204 Labeling Approved July 9, 2019 Standard
Supplement 5196 Efficacy Approved September 27, 2016 Standard
Supplement 5194 Labeling Approved December 22, 2015 Standard
Supplement 5172 Labeling Approved March 10, 2015 Standard
Supplement 5179 Labeling Approved April 24, 2014 Standard
Supplement 5178 Labeling Approved April 24, 2014 Standard
Supplement 5140 Labeling Approved April 19, 2013 Standard
Supplement 5121 Manufacturing (CMC) Approved December 21, 2012 —
Supplement 5062 Labeling Approved June 30, 2005 Standard
Supplement 5030 Labeling Approved December 23, 2004 Standard
Supplement 5052 Supplement Approved December 17, 2004 —
Supplement 5027 Efficacy Approved March 26, 2004 Standard
Supplement 5010 Efficacy Approved May 2, 2003 Standard
Original application 1 Type 1 - New Molecular Entity Approved March 7, 2002 Unknown

Review documents

  • 0 · Supplement · July 31, 2023
  • 0 · Supplement · July 31, 2023
  • 0 · Supplement · July 31, 2023
  • 0 · Supplement · November 5, 2021
  • 0 · Supplement · November 5, 2021
  • 0 · Supplement · January 7, 2021
  • 0 · Supplement · May 28, 2020
  • 0 · Supplement · May 28, 2020
  • 0 · Supplement · May 27, 2020
  • 0 · Supplement · May 27, 2020
  • 0 · Supplement · July 11, 2019
  • 0 · Supplement · July 10, 2019
  • 0 · Supplement · September 30, 2016
  • 0 · Supplement · September 30, 2016
  • 0 · Supplement · December 28, 2015
  • 0 · Supplement · December 23, 2015
  • 0 · Supplement · March 12, 2015
  • 0 · Supplement · March 11, 2015
  • 0 · Supplement · April 28, 2014
  • 0 · Supplement · April 28, 2014
  • 0 · Supplement · April 25, 2014
  • 0 · Supplement · April 25, 2014
  • 0 · Supplement · April 24, 2013
  • 0 · Supplement · April 23, 2013
  • 0 · Supplement · December 28, 2012
  • 0 · Supplement · December 28, 2012
  • 0 · Supplement · July 21, 2005
  • 0 · Supplement · July 21, 2005
  • 0 · Supplement · January 26, 2005
  • 0 · Supplement · January 26, 2005

Adverse event reports

Source: openFDA FAERS
192,063
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: INTERFERON BETA-1A. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
44087-3322-1 44087-3322 EMD Serono, Inc. 12 PACKAGE in 1 CARTON (44087-3322-1) / .5 mL in 1 PACKAGE (44087-3322-9) December 21, 2012
44087-3344-1 44087-3344 EMD Serono, Inc. 12 PACKAGE in 1 CARTON (44087-3344-1) / .5 mL in 1 PACKAGE (44087-3344-9) December 21, 2012
44087-3322 44087-3322 EMD Serono, Inc. — December 21, 2012
44087-3344 44087-3344 EMD Serono, Inc. — December 21, 2012

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 9 sections on this page.