LETYBO
- Product NDC
- 81165-100
- 11-digit product format
- 811650100
- Labeler code
- 81165
- Product ID
- 81165-100_2784ba3d-d3f8-1059-e063-6394a90a2ff1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- letibotulinumtoxinA-wlbg
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Hugel, Inc.
- Application
- BLA761225
- Marketing category
- BLA
- Marketing start
- 2024-07-30
- Substance
- LETIBOTULINUMTOXINA
- Active strength
- 100 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LETYBO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LETIBOTULINUMTOXINA | 100 U/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W5O50S8A59 |
| Rxcui | 2689290, 2689297, 2689299, 2689301 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81165-100-01 | LETYBO | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
| 81165-100-01 | LETYBO | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81165-100 | LETYBO (LETIBOTULINUMTOXINA-WLBG) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUGEL, INC.] | 4 | Current NDC, 2 package rows | 20241127_910e5d0e-4d0b-4de8-8e2d-97879a044181.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 81165-100-01 | 81165010001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (81165-100-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2024-07-30 | No | No | Historical |