Xeomin
- Product NDC
- 46783-165
- 11-digit product format
- 467830165
- Labeler code
- 46783
- Product ID
- 46783-165_cc302fc7-e87f-41ff-b716-388abdbf957a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- incobotulinumtoxinA
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Merz North America, Inc.
- Application
- BLA125360
- Marketing category
- BLA
- Marketing start
- 2011-08-01
- Substance
- BOTULINUM TOXIN TYPE A
- Active strength
- 50 [USP'U]/1
- Pharmacologic classes
- Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Xeomin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BOTULINUM TOXIN TYPE A | 50 [USP'U]/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | E211KPY694 |
| Rxcui | 1009456, 1009459, 1732157, 1732161 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46783-165-01 | Xeomin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 26 |
| 46783-165-01 | Xeomin | 1 in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Botulinum Toxin Type A | ACTIVE INGREDIENT | E211KPY694 | XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.] | 7 | |
| Botulinum Toxin Type A | ACTIVE MOIETY | E211KPY694 | XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.] | 7 | |
| Albumin Human | INACTIVE INGREDIENT | ZIF514RVZR | XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.] | 7 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46783-165 | XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.] | 24 | Current NDC, Legacy NDC, 2 package rows | 20241222_3f35d6e0-3450-4abc-a0da-cc7b277e7c6e.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 |
|---|
| 46783-165-01 | 46783016501 | 1 VIAL, SINGLE-USE in 1 CARTON (46783-165-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE | 2011-08-01 | 0000-00-00 | No | No | Current |