Myobloc (Page 7 of 7)
PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Carton
NDC 10454-710-10
Rx Only
rimabotulinumtoxinB
MYOBLOC
®
Injection
FOR INTRAMUSCULAR AND
INTRAGLANDULAR USE
2,500 Units/0.5 mL
WARNING: Dosing units of botulinum toxins are
not interchangeable between commercial products.
Single-dose Vial
Discard Unused Portion
Dispense the accompanying Medication Guide to each patient.
SOLSTICE ® NEUROSCIENCES
US WorldMeds ®
PRINCIPAL DISPLAY PANEL — 1 mL Vial Carton
NDC 10454-711-10
Rx Only
rimabotulinumtoxinB
MYOBLOC
®
Injection
FOR INTRAMUSCULAR AND
INTRAGLANDULAR USE
5,000 Units/1 mL
WARNING: Dosing units of botulinum toxins are
not interchangeable between commercial products.
Single-dose Vial
Discard Unused Portion
Dispense the accompanying Medication Guide to each patient.
SOLSTICE ® NEUROSCIENCES
US WorldMeds ®
PRINCIPAL DISPLAY PANEL — 2 mL Vial Carton
NDC 10454-712-10
Rx Only
rimabotulinumtoxinB
MYOBLOC
®
Injection
FOR INTRAMUSCULAR AND
INTRAGLANDULAR USE
10,000 Units/2 mL
(5,000 Units/mL)
WARNING: Dosing units of botulinum toxins are
not interchangeable between commercial products.
Single-dose Vial
Discard Unused Portion
Dispense the accompanying Medication Guide to each patient.
SOLSTICE ® NEUROSCIENCES
US WorldMeds ®
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Labeler — Solstice Neurosciences, LLC (780448184) |
Registrant — MDD US Operations, LLC (087875626) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Catalent Pharma Solutions, LLC | 014167995 | analysis (10454-710), analysis (10454-711), analysis (10454-712) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Eurofins Lancaster Laboratories, Inc. | 069777290 | analysis (10454-710), analysis (10454-711), analysis (10454-712) |
Establishment | |||
Name | Address | ID/FEI | Operations |
IDT Biologica GmbH | 332119734 | analysis (10454-710), analysis (10454-711), analysis (10454-712) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Merz Pharma GmbH & Co. KGaA | 342543051 | analysis (10454-710), analysis (10454-711), analysis (10454-712), manufacture (10454-710), manufacture (10454-711), manufacture (10454-712), api manufacture (10454-710), api manufacture (10454-711), api manufacture (10454-712) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Merz Pharma GmbH & Co. KGaA | 342543179 | pack (10454-710), pack (10454-711), pack (10454-712), label (10454-710), label (10454-711), label (10454-712) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Pacific BioLabs | 797419769 | analysis (10454-710), analysis (10454-711), analysis (10454-712) |
Revised: 12/2023 Solstice Neurosciences, LLC
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