Cevimeline Hydrochloride NDC 0054-0334

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0334Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0334Add 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
0054-0334-25	00054033425	100 CAPSULE in 1 BOTTLE (0054-0334-25)Marketed from Jul 8, 2013

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091591
Marketing start: Jul 8, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 0054-0334_3cca3720-dca8-40cf-8de7-8f3444125eceSPL ID 3cca3720-dca8-40cf-8de7-8f3444125eceSPL set ID 1167360c-7e0f-4619-9d1a-ad4ee56cab71RxCUI 309140UNII P81Q6V85NPUPC 0300540334253
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

N400054033425 followed by a unit qualifier and the quantity

Package 00054-0334-25. 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 Jan 8, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cevimeline hydrochloride 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 091591

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

FDA NDC Directory listings under ANDA 091591
Product	Strength	Form · route	Labeler	Product NDC
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2264