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

Myobloc

rimabotulinumtoxinB · Injection, Solution

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

Overview

Brand name
Myobloc
Generic name
rimabotulinumtoxinB
Dosage form
Injection, Solution
Route
Intramuscular
Marketing category
BLA · BLA
Labeler
Solstice Neurosciences, LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
3
Data completeness
52% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Rimabotulinumtoxinb 10000 [USP'U]/2mL — —
Rimabotulinumtoxinb 2500 [USP'U]/.5mL — —
Rimabotulinumtoxinb 5000 [USP'U]/mL — —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Intramuscular
Presentations
6

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
Acetylcholine Release Inhibitor [EPC] EPC 6 members — no class page
Acetylcholine Release Inhibitors [MoA] MoA 6 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
103846
Application type
BLA · Biologics License Application
Approval date
December 8, 2000
Sponsor
ELAN PHARM
Products on application
1
Submissions recorded
5
Products approved under application 103846.
Product Trade name Form Strength Ingredient Status TE Flags
103846-001 MYOBLOC VIAL Botulinum Toxin Type B Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 103846.
Type No. Action Status Date Review
Supplement 5195 Labeling Approved March 10, 2021 Standard
Supplement 5190 Efficacy Approved August 20, 2019 Standard
Supplement 5156 Labeling Approved June 13, 2012 Standard
Supplement 5120 Labeling Approved July 31, 2009 Standard
Original application 1 Type 1 - New Molecular Entity Approved December 8, 2000 Standard

Review documents

  • 0 · Supplement · March 11, 2021
  • 0 · Supplement · March 11, 2021
  • 0 · Supplement · March 11, 2021
  • 0 · Supplement · August 21, 2019
  • 0 · Supplement · August 21, 2019
  • 0 · Supplement · August 21, 2019
  • 0 · Supplement · June 15, 2012
  • 0 · Supplement · August 7, 2009
  • 0 · Supplement · August 7, 2009
  • 0 · Original application · August 12, 2008
  • 0 · Original application · March 17, 2004
  • 0 · Original application · March 17, 2004
  • 0 · Original application · March 17, 2004

Adverse event reports

Source: openFDA FAERS
0
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.

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
10454-710-10 10454-710 Solstice Neurosciences, LLC 1 VIAL, SINGLE-USE in 1 CARTON (10454-710-10) / .5 mL in 1 VIAL, SINGLE-USE January 1, 2020
10454-711-10 10454-711 Solstice Neurosciences, LLC 1 VIAL, SINGLE-USE in 1 CARTON (10454-711-10) / 1 mL in 1 VIAL, SINGLE-USE January 1, 2020
10454-712-10 10454-712 Solstice Neurosciences, LLC 1 VIAL, SINGLE-USE in 1 CARTON (10454-712-10) / 2 mL in 1 VIAL, SINGLE-USE January 1, 2020
10454-710 10454-710 Solstice Neurosciences, LLC — December 8, 2000
10454-711 10454-711 Solstice Neurosciences, LLC — December 8, 2000
10454-712 10454-712 Solstice Neurosciences, LLC — December 8, 2000

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
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 8 sections on this page.