NDC codes

FDA NDC Directory
Product NDC (as listed)15054-0500Labeler and product segments. Claims need a package NDC.
Product NDC at billing width15054-0500Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
15054-0500-1150540500011 VIAL in 1 CARTON (15054-0500-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Nov 2, 2009
15054-0500-2150540500022 VIAL in 1 CARTON (15054-0500-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Nov 2, 2009
15054-0500-9150540500091 VIAL in 1 CARTON (15054-0500-9) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Nov 2, 2009 · Sample package

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 — 500 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 15054-0500_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.

How CPT relates to drug billing

NDC on a medical claim

N415054050001 followed by a unit qualifier and the quantity

Package 15054-0500-01. 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)

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 125274

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125274
ProductStrengthForm · routeLabelerProduct NDC
Dysportbotulinum toxin type aBotulinum toxin type a 300 U/1Injection, Powder, Lyophilized, For solutionIntramuscularGalderma Laboratories, L.P.0299-5962
Dysportbotulinum toxin type aBotulinum toxin type a 300 U/1Injection, Powder, Lyophilized, For solutionIntramuscularIpsen Biopharmaceuticals, Inc.15054-0530

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Dysport (botulinum toxin type a) NDC 15054-0500 | Med-Code