NDC 10454-712

Myobloc

Rimabotulinumtoxinb

Myobloc is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Solstice Neurosciences, Llc. The primary component is Rimabotulinumtoxinb.

• Product ID: 10454-712_29e1ab0b-160f-4568-8dca-0c8f09f52b3e
• NDC: 10454-712
• Product Type: Human Prescription Drug
• Proprietary Name: Myobloc
• Generic Name: Rimabotulinumtoxinb
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2000-12-08
• Marketing Category: BLA / BLA
• Application Number: BLA103846
• Labeler Name: Solstice Neurosciences, LLC
• Substance Name: RIMABOTULINUMTOXINB
• Active Ingredient Strength: 10000 [USP'U]/2mL
• Pharm Classes: Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 10454-712-10

1 VIAL, SINGLE-USE in 1 CARTON (10454-712-10) > 2 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2020-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10454-712-10 [10454071210]

Myobloc INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103846
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2000-12-08

Drug Details

Active Ingredients

Ingredient	Strength
RIMABOTULINUMTOXINB	10000 [USP'U]/2mL

OpenFDA Data

• SPL SET ID: 675cb354-9d13-482e-8ac2-22f709c58b4f
• Manufacturer:
  • Solstice Neurosciences, LLC
• UNII:
  • 0Y70779M1F
• RxNorm Concept Unique ID - RxCUI:
  • 1736645
  • 1736646
  • 1736647
  • 1736640
  • 1736642
  • 1736648
• UPC Code:
  • 0310454711101
  • 0310454710104

Pharmacological Class

• Acetylcholine Release Inhibitor [EPC]
• Acetylcholine Release Inhibitors [MoA]

NDC Crossover Matching brand name "Myobloc" or generic name "Rimabotulinumtoxinb"

NDC	Brand Name	Generic Name
10454-710	Myobloc	rimabotulinumtoxinB
10454-711	Myobloc	rimabotulinumtoxinB
10454-712	Myobloc	rimabotulinumtoxinB