Ontralfy (tizanidine hydrochloride) NDC 69528-310

NDC codes

FDA NDC Directory

Product NDC (as listed)69528-310Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69528-0310Add 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 NDC	11-digit (billing)	Package	Copy
69528-310-16	69528031016	473 mL in 1 BOTTLE, PLASTIC (69528-310-16)Marketed from Oct 1, 2025

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): Ontralfy
Generic name (nonproprietary): tizanidine hydrochloride
Active ingredients: Tizanidine hydrochloride — 2 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Rosemont Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216190
Marketing start: Mar 31, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 69528-310_4b1edc20-775b-bb26-e063-6394a90acd08SPL ID 4b1edc20-775b-bb26-e063-6394a90acd08SPL set ID 7b88c338-c0b7-4c08-bef6-a4ffc2f25df7RxCUI 2709432, 2709438UNII B53E3NMY5CUPC 0369528310160
Pharmacologic class: Central alpha-2 Adrenergic Agonist

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469528031016 followed by a unit qualifier and the quantity

Package 69528-0310-16. 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 Oct 25, 2025.

Indications (excerpt from the label)

Ontralfy is indicated for the treatment of spasticity in adults. Ontralfy is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)