Prescription drug · BLA
Letybo (Letibotulinumtoxina-wlbg) NDC 81165-050
Letibotulinumtoxina 50 U/1 · Injection, Powder, Lyophilized, For solution · Intramuscular · Hugel, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81165-050-01 | 81165005001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (81165-050-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Jul 30, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Letybo
- Generic name (nonproprietary)
- letibotulinumtoxina-wlbg
- Active ingredients
- Letibotulinumtoxina — 50 U/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular
- Labeler
- Hugel, Inc.NDC labeler code 81165
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761225
- Marketing start
- Listing expires
- Other FDA classes
- Acetylcholine Release Inhibitors (Mechanism)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 81165-050_2784ba3d-d3f8-1059-e063-6394a90a2ff1SPL ID 2784ba3d-d3f8-1059-e063-6394a90a2ff1SPL set ID 910e5d0e-4d0b-4de8-8e2d-97879a044181RxCUI 2689290, 2689297, 2689299, 2689301UNII W5O50S8A59
- Pharmacologic class
- Acetylcholine Release Inhibitor; Neuromuscular Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N481165005001followed by a unit qualifier and the quantityPackage 81165-0050-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
LETYBO is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. LETYBO is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 81165-050
- What is NDC 81165-050?
- 81165-050 is the product NDC for Letybo (letibotulinumtoxina-wlbg), Letibotulinumtoxina 50 U/1 injection, powder, lyophilized, for solution, listed with the FDA by Hugel, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Letybo (LetibotulinumtoxinA-wlbg).
- What is the active ingredient?
- Letibotulinumtoxina.
- Who is the labeler?
- Hugel, Inc., NDC labeler code 81165. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Letybo?
- 1 other product NDC are listed under this name. See all Letybo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Letybo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Letyboletibotulinumtoxina-wlbg | Letibotulinumtoxina 100 U/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Hugel, Inc. | 81165-100 | 81165-0100-01 |
Other NDCs under BLA 761225
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Letyboletibotulinumtoxina-wlbg | Letibotulinumtoxina 100 U/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Hugel, Inc. | 81165-100 |