NDC codes

FDA NDC Directory
Product NDC (as listed)10454-711Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10454-0711Add 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
10454-711-10104540711101 VIAL, SINGLE-USE in 1 CARTON (10454-711-10) / 1 mL in 1 VIAL, SINGLE-USEMarketed from Jan 1, 2020

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)
Myobloc
Generic name (nonproprietary)
rimabotulinumtoxinb
Active ingredients
Rimabotulinumtoxinb — 5000 [USP'U]/mL
Dosage form
Injection, Solution
Route
Intramuscular
Labeler
Solstice Neurosciences, LLCNDC labeler code 10454
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 103846
Marketing start
Listing expires
Other FDA classes
Acetylcholine Release Inhibitors (Mechanism)
Identifiers
Product ID 10454-711_5b8c0152-e0d9-843c-e063-6394a90a52e3SPL ID 5b8c0152-e0d9-843c-e063-6394a90a52e3
Pharmacologic class
Acetylcholine Release Inhibitor

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

N410454071110 followed by a unit qualifier and the quantity

Package 10454-0711-10. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 10454-711

What is NDC 10454-711?
10454-711 is the product NDC for Myobloc (rimabotulinumtoxinb), Rimabotulinumtoxinb 5000 [USP'U]/mL injection, solution, listed with the FDA by Solstice Neurosciences, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Myobloc (RimabotulinumtoxinB).
What is the active ingredient?
Rimabotulinumtoxinb.
Who is the labeler?
Solstice Neurosciences, LLC, NDC labeler code 10454. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Myobloc?
2 other product NDCs are listed under this name. See all Myobloc NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Myobloc NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MyoblocrimabotulinumtoxinbRimabotulinumtoxinb 2500 [USP'U]/.5mLInjection, SolutionIntramuscularSolstice Neurosciences, LLC10454-71010454-0710-10
MyoblocrimabotulinumtoxinbRimabotulinumtoxinb 10000 [USP'U]/2mLInjection, SolutionIntramuscularSolstice Neurosciences, LLC10454-71210454-0712-10

Other NDCs under BLA 103846

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

FDA NDC Directory listings under BLA 103846
ProductStrengthForm · routeLabelerProduct NDC
MyoblocrimabotulinumtoxinbRimabotulinumtoxinb 2500 [USP'U]/.5mLInjection, SolutionIntramuscularSolstice Neurosciences, LLC10454-710
MyoblocrimabotulinumtoxinbRimabotulinumtoxinb 10000 [USP'U]/2mLInjection, SolutionIntramuscularSolstice Neurosciences, LLC10454-712

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