Cevimeline Hydrochloride NDC 72578-208

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-208Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0208Add 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
72578-208-01	72578020801	100 CAPSULE in 1 BOTTLE (72578-208-01)Marketed from Apr 15, 2026

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): Cevimeline Hydrochloride
Generic name (nonproprietary): cevimeline hydrochloride
Active ingredients: Cevimeline hydrochloride — 30 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Viona Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 220267
Marketing start: Apr 15, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 72578-208_4518aba1-9402-4137-a7f0-6b24ec60efdaSPL ID 4518aba1-9402-4137-a7f0-6b24ec60efdaSPL set ID ca0409bc-2685-4ffd-b806-04898902a597RxCUI 309140UNII P81Q6V85NP
Pharmacologic class: Cholinergic Receptor 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

N472578020801 followed by a unit qualifier and the quantity

Package 72578-0208-01. 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 Jul 14, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with Sjögren's Syndrome.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 220267

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

FDA NDC Directory listings under ANDA 220267
Product	Strength	Form · route	Labeler	Product NDC
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1982