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Myobloc

These highlights do not include all the information needed to use MYOBLOC safely and effectively. See full prescribing information for MYOBLOC . MYOBLOC (rimabotulinumtoxinB) injection, for intramuscular or intraglandular use Initial U.S. Approval: 2000

Approved
Approval ID

675cb354-9d13-482e-8ac2-22f709c58b4f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 20, 2023

Manufacturers
FDA

Solstice Neurosciences, LLC

DUNS: 780448184

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

rimabotulinumtoxinB

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10454-712
Application NumberBLA103846
Product Classification
M
Marketing Category
C73585
G
Generic Name
rimabotulinumtoxinB
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (7)

ALBUMIN HUMANInactive
Code: ZIF514RVZR
Classification: IACT
SODIUM SUCCINATE HEXAHYDRATEInactive
Code: U16QOD6C4E
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CAPRYLATEInactive
Code: 9XTM81VK2B
Classification: IACT
N-ACETYL-DL-TRYPTOPHAN SODIUMInactive
Code: 3EN9H0M2FX
Classification: IACT
RIMABOTULINUMTOXINBActive
Quantity: 10000 [USP'U] in 2 mL
Code: 0Y70779M1F
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

rimabotulinumtoxinB

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10454-711
Application NumberBLA103846
Product Classification
M
Marketing Category
C73585
G
Generic Name
rimabotulinumtoxinB
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (7)

SODIUM SUCCINATE HEXAHYDRATEInactive
Code: U16QOD6C4E
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALBUMIN HUMANInactive
Code: ZIF514RVZR
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CAPRYLATEInactive
Code: 9XTM81VK2B
Classification: IACT
N-ACETYL-DL-TRYPTOPHAN SODIUMInactive
Code: 3EN9H0M2FX
Classification: IACT
RIMABOTULINUMTOXINBActive
Quantity: 5000 [USP'U] in 1 mL
Code: 0Y70779M1F
Classification: ACTIB

rimabotulinumtoxinB

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10454-710
Application NumberBLA103846
Product Classification
M
Marketing Category
C73585
G
Generic Name
rimabotulinumtoxinB
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (7)

SODIUM SUCCINATE HEXAHYDRATEInactive
Code: U16QOD6C4E
Classification: IACT
N-ACETYL-DL-TRYPTOPHAN SODIUMInactive
Code: 3EN9H0M2FX
Classification: IACT
ALBUMIN HUMANInactive
Code: ZIF514RVZR
Classification: IACT
SODIUM CAPRYLATEInactive
Code: 9XTM81VK2B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
RIMABOTULINUMTOXINBActive
Quantity: 2500 [USP'U] in 0.5 mL
Code: 0Y70779M1F
Classification: ACTIB

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