Prescription drug · BLA
Dysport (botulinum toxin type a) NDC 15054-0530
Botulinum toxin type a 300 U/1 · Injection, Powder, Lyophilized, For solution · Intramuscular · Ipsen Biopharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 15054-0530-6 | 15054053006 | 1 VIAL in 1 CARTON (15054-0530-6) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Nov 2, 2009 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Dysport
- Generic name (nonproprietary)
- botulinum toxin type a
- Active ingredients
- Botulinum toxin type a — 300 U/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125274
- Marketing start
- Listing expires
- Other FDA classes
- Acetylcholine Release Inhibitors (Mechanism)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 15054-0530_44512f6b-6a35-4db5-ba17-fe2fe3ec5170SPL ID 44512f6b-6a35-4db5-ba17-fe2fe3ec5170SPL set ID 97513722-8426-4ce3-b85d-0e08e436a140RxCUI 1789950, 1789953, 1789956, 1789958UNII E211KPY694UPC 0315054050018
- 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
N415054053006followed by a unit qualifier and the quantityPackage 15054-0530-06. 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)
DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: The treatment of cervical dystonia in adults ( 1.1 ) The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age ( 1.2 ) The treatment of spasticity in patients 2 years of age and older ( 1.3 ) 1.1 Cervical Dystonia DYSPORT is indicated for the treatment of cervical dystonia in adults. 1.2 Glabellar Lines DYSPORT is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults less than 65 years…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 125274
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 |
|---|---|---|---|---|
| Dysportbotulinum toxin type a | Botulinum toxin type a 300 U/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Galderma Laboratories, L.P. | 0299-5962 |
| Dysportbotulinum toxin type a | Botulinum toxin type a 500 U/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Ipsen Biopharmaceuticals, Inc. | 15054-0500 |