FDA.reportPublic FDA data

Myobloc

Product NDC
10454-712
11-digit product format
104540712
Labeler code
10454
Product ID
10454-712_41c1a48c-e928-1099-e063-6294a90a359f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rimabotulinumtoxinB
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Solstice Neurosciences, LLC
Application
BLA103846
Marketing category
BLA
Marketing start
2000-12-08
Substance
RIMABOTULINUMTOXINB
Active strength
10000 [USP'U]/2mL
Pharmacologic classes
Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Myobloc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIMABOTULINUMTOXINB10000 [USP'U]/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0Y70779M1FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1736640Internal RxNorm lookup
1736642Internal RxNorm lookup
1736645Internal RxNorm lookup
1736646Internal RxNorm lookup
1736647Internal RxNorm lookup
1736648Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
675cb354-9d13-482e-8ac2-22f709c58b4fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
776b5b75-54f9-4616-834e-4214179c2487Product name120200204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10454-712-10Myobloc1 in 1 CARTONINJECTION, SOLUTION120
10454-712-10Myobloc2 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION220

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10454-712-10ML - Milliliter10454-71209f2235a-fe19-4bf1-8209-fb21324c278712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
rimabotulinumtoxinBACTIVE INGREDIENT0Y70779M1FMYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC]5
rimabotulinumtoxinBACTIVE MOIETY0Y70779M1FMYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC]5
albumin (human)INACTIVE INGREDIENTZIF514RVZRMYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC]5
hydrochloric acidINACTIVE INGREDIENTQTT17582CBMYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC]5
sodium acetyltryptophanateINACTIVE INGREDIENT3EN9H0M2FXMYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC]5
sodium caprylateINACTIVE INGREDIENT9XTM81VK2BMYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC]5
sodium chlorideINACTIVE INGREDIENT451W47IQ8XMYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC]5
sodium succinate hexahydrateINACTIVE INGREDIENTU16QOD6C4EMYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10454-712MYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC]17Current NDC, Legacy NDC, 2 package rows20241013_675cb354-9d13-482e-8ac2-22f709c58b4f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyoblocRIMABOTULINUMTOXINBSolstice Neurosciences, LLC675cb354-9d13-482e-8ac2-22f709c58b4f2025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103846
ndc (product): 10454-712

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103846MyoblocrimabotulinumtoxinB351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736646MYOBLOC 10,000 UNT in 2 ML InjectionPSN675cb354-9d13-482e-8ac2-22f709c58b4f20
1736642MYOBLOC 2500 UNT in 0.5 ML InjectionPSN675cb354-9d13-482e-8ac2-22f709c58b4f20
1736648MYOBLOC 5000 UNT in 1 ML InjectionPSN675cb354-9d13-482e-8ac2-22f709c58b4f20
1736645rimabotulinumtoxinB 10,000 UNT in 2 ML InjectionPSN675cb354-9d13-482e-8ac2-22f709c58b4f20
1736640rimabotulinumtoxinB 2500 UNT in 0.5 ML InjectionPSN675cb354-9d13-482e-8ac2-22f709c58b4f20
1736647rimabotulinumtoxinB 5000 UNT in 1 ML InjectionPSN675cb354-9d13-482e-8ac2-22f709c58b4f20
17366420.5 ML rimabotulinumtoxinB 5000 UNT/ML Injection [Myobloc]SBD675cb354-9d13-482e-8ac2-22f709c58b4f20
17366481 ML rimabotulinumtoxinB 5000 UNT/ML Injection [Myobloc]SBD675cb354-9d13-482e-8ac2-22f709c58b4f20
17366462 ML rimabotulinumtoxinB 5000 UNT/ML Injection [Myobloc]SBD675cb354-9d13-482e-8ac2-22f709c58b4f20
17366400.5 ML rimabotulinumtoxinB 5000 UNT/ML InjectionSCD675cb354-9d13-482e-8ac2-22f709c58b4f20
17366471 ML rimabotulinumtoxinB 5000 UNT/ML InjectionSCD675cb354-9d13-482e-8ac2-22f709c58b4f20
17366452 ML rimabotulinumtoxinB 5000 UNT/ML InjectionSCD675cb354-9d13-482e-8ac2-22f709c58b4f20
1736646Myobloc 10000 UNT per 2 ML InjectionSY675cb354-9d13-482e-8ac2-22f709c58b4f20
1736642Myobloc 2500 UNT per 0.5 ML InjectionSY675cb354-9d13-482e-8ac2-22f709c58b4f20
1736648Myobloc 5000 UNT per 1 ML InjectionSY675cb354-9d13-482e-8ac2-22f709c58b4f20
1736645rimabotulinumtoxinB 10000 UNT per 2 ML InjectionSY675cb354-9d13-482e-8ac2-22f709c58b4f20
1736640rimabotulinumtoxinB 2500 UNT per 0.5 ML InjectionSY675cb354-9d13-482e-8ac2-22f709c58b4f20
1736647rimabotulinumtoxinB 5000 UNT per 1 ML InjectionSY675cb354-9d13-482e-8ac2-22f709c58b4f20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10454-712-10104540712101 VIAL, SINGLE-USE in 1 CARTON (10454-712-10) / 2 mL in 1 VIAL, SINGLE-USE2020-01-010000-00-00NoNoCurrent