cevimeline hydrochloride NDC 40032-999

NDC codes

FDA NDC Directory

Product NDC (as listed)40032-999Labeler and product segments. Claims need a package NDC.

Product NDC at billing width40032-0999Add 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
40032-999-01	40032099901	100 CAPSULE in 1 BOTTLE (40032-999-01)Marketed from Dec 30, 2016
40032-999-03	40032099903	30 CAPSULE in 1 BOTTLE (40032-999-03)Marketed from Dec 30, 2016
40032-999-05	40032099905	500 CAPSULE in 1 BOTTLE (40032-999-05)Marketed from Dec 30, 2016

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: Novel Laboratories, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204746
Marketing start: Dec 30, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 40032-999_c42fae45-bbcf-40b6-911d-ebe3893f10baSPL ID c42fae45-bbcf-40b6-911d-ebe3893f10baSPL set ID d7432a48-1142-431e-997f-8419dc724824RxCUI 309140UNII P81Q6V85NPUPC 0340032999010, 0340032999058, 0340032999034
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

N440032099901 followed by a unit qualifier and the quantity

Package 40032-0999-01. 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 Feb 9, 2016.

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 204746

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

FDA NDC Directory listings under ANDA 204746
Product	Strength	Form · route	Labeler	Product NDC
cevimeline hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Lupin Pharmaceuticals,Inc.	43386-999