Cevimeline Hydrochloride NDC 63629-9863

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-9863Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-9863Add 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
63629-9863-1	63629986301	30 CAPSULE in 1 BOTTLE (63629-9863-1)Marketed from Nov 30, 2023
63629-9863-2	63629986302	60 CAPSULE in 1 BOTTLE (63629-9863-2)Marketed from Sep 5, 2024
63629-9863-3	63629986303	90 CAPSULE in 1 BOTTLE (63629-9863-3)Marketed from Sep 5, 2024

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): Cevimeline Hydrochloride
Generic name (nonproprietary): cevimeline hydrochloride
Active ingredients: Cevimeline hydrochloride — 30 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203775
Marketing start: Jun 17, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 63629-9863_b8a8d949-15e3-4dc7-afd2-c9621a5c7c83SPL ID b8a8d949-15e3-4dc7-afd2-c9621a5c7c83SPL set ID 51307f82-66f2-41c7-80ff-174d7e50f7eeRxCUI 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

N463629986301 followed by a unit qualifier and the quantity

Package 63629-9863-01. 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 Sep 5, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cevimeline is 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 203775

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

FDA NDC Directory listings under ANDA 203775
Product	Strength	Form · route	Labeler	Product NDC
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	16571-657
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	ASCLEMED USA INC.	87063-180