Myobloc
- Product NDC
- 10454-711
- 11-digit product format
- 104540711
- Labeler code
- 10454
- Product ID
- 10454-711_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
- 5000 [USP'U]/mL
- 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| Ingredient | Strength |
|---|
| RIMABOTULINUMTOXINB | 5000 [USP'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0Y70779M1F |
| Rxcui | 1736640, 1736642, 1736645, 1736646, 1736647, 1736648 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10454-711-10 | Myobloc | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 20 |
| 10454-711-10 | Myobloc | 1 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 1 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| rimabotulinumtoxinB | ACTIVE INGREDIENT | 0Y70779M1F | MYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC] | 5 | |
| rimabotulinumtoxinB | ACTIVE MOIETY | 0Y70779M1F | MYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC] | 5 | |
| albumin (human) | INACTIVE INGREDIENT | ZIF514RVZR | MYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC] | 5 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | MYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC] | 5 | |
| sodium acetyltryptophanate | INACTIVE INGREDIENT | 3EN9H0M2FX | MYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC] | 5 | |
| sodium caprylate | INACTIVE INGREDIENT | 9XTM81VK2B | MYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC] | 5 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | MYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC] | 5 | |
| sodium succinate hexahydrate | INACTIVE INGREDIENT | U16QOD6C4E | MYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10454-711 | MYOBLOC (RIMABOTULINUMTOXINB) INJECTION, SOLUTION [SOLSTICE NEUROSCIENCES, LLC] | 17 | Current NDC, Legacy NDC, 2 package rows | 20241013_675cb354-9d13-482e-8ac2-22f709c58b4f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10454-711-10 | 10454071110 | 1 VIAL, SINGLE-USE in 1 CARTON (10454-711-10) / 1 mL in 1 VIAL, SINGLE-USE | 2020-01-01 | 0000-00-00 | No | No | Current |