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 -- 0.5 mL Vial Carton
(click image for full-size original)

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 -- 1 mL Vial Carton
(click image for full-size original)

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 ®

PRINCIPAL DISPLAY PANEL -- 2 mL Vial Carton
(click image for full-size original)
MYOBLOC rimabotulinumtoxinb injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10454-710
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIMABOTULINUMTOXINB (RIMABOTULINUMTOXINB) RIMABOTULINUMTOXINB 2500 [USP’U] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SUCCINATE HEXAHYDRATE
SODIUM CHLORIDE
ALBUMIN HUMAN
N-ACETYL-DL-TRYPTOPHAN SODIUM
SODIUM CAPRYLATE
HYDROCHLORIC ACID
Product Characteristics
Color yellow (colorless to light yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10454-710-10 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 0.5 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (10454-710-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103846 12/08/2000
MYOBLOC rimabotulinumtoxinb injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10454-711
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIMABOTULINUMTOXINB (RIMABOTULINUMTOXINB) RIMABOTULINUMTOXINB 5000 [USP’U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SUCCINATE HEXAHYDRATE
SODIUM CHLORIDE
ALBUMIN HUMAN
N-ACETYL-DL-TRYPTOPHAN SODIUM
SODIUM CAPRYLATE
HYDROCHLORIC ACID
Product Characteristics
Color yellow (colorless to light yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10454-711-10 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 1 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (10454-711-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103846 12/08/2000
MYOBLOC rimabotulinumtoxinb injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10454-712
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIMABOTULINUMTOXINB (RIMABOTULINUMTOXINB) RIMABOTULINUMTOXINB 10000 [USP’U] in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SUCCINATE HEXAHYDRATE
SODIUM CHLORIDE
ALBUMIN HUMAN
N-ACETYL-DL-TRYPTOPHAN SODIUM
SODIUM CAPRYLATE
HYDROCHLORIC ACID
Product Characteristics
Color yellow (colorless to light yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10454-712-10 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 2 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (10454-712-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103846 12/08/2000
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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