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 ID10454-712_29e1ab0b-160f-4568-8dca-0c8f09f52b3e
NDC10454-712
Product TypeHuman Prescription Drug
Proprietary NameMyobloc
Generic NameRimabotulinumtoxinb
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2000-12-08
Marketing CategoryBLA / BLA
Application NumberBLA103846
Labeler NameSolstice Neurosciences, LLC
Substance NameRIMABOTULINUMTOXINB
Active Ingredient Strength10000 [USP'U]/2mL
Pharm ClassesAcetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10454-712-10

1 VIAL, SINGLE-USE in 1 CARTON (10454-712-10) > 2 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2020-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10454-712-10 [10454071210]

Myobloc INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103846
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-12-08

Drug Details

Active Ingredients

IngredientStrength
RIMABOTULINUMTOXINB10000 [USP'U]/2mL

OpenFDA Data

SPL SET ID:675cb354-9d13-482e-8ac2-22f709c58b4f
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    10454-710MyoblocrimabotulinumtoxinB
    10454-711MyoblocrimabotulinumtoxinB
    10454-712MyoblocrimabotulinumtoxinB

    Trademark Results [Myobloc]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MYOBLOC
    MYOBLOC
    76067873 2628983 Live/Registered
    SOLSTICE NEUROSCIENCES, LLC
    2000-06-09

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.