What is NDC 63304-479?

63304-479 is the product NDC for Cevimeline, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cevimeline?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cevimeline NDC 63304-479 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-479Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0479Add 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
63304-479-01	63304047901	100 CAPSULE in 1 BOTTLE (63304-479-01)Marketed from Mar 10, 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
Generic name (nonproprietary): cevimeline
Active ingredients: Cevimeline hydrochloride — 30 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020989
Marketing start: Mar 10, 2016
Marketing end: Apr 30, 2027
Other FDA classes: Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 63304-479_558c3230-3788-4ef0-a5b5-3c06870317a9SPL ID 558c3230-3788-4ef0-a5b5-3c06870317a9SPL set ID 773a19e8-4c3e-4414-99a6-aea98c9790eeRxCUI 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

N463304047901 followed by a unit qualifier and the quantity

Package 63304-0479-01. 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 15, 2022.

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)

About NDC 63304-479

What is NDC 63304-479?: 63304-479 is the product NDC for Cevimeline, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cevimeline.
What is the active ingredient?: Cevimeline hydrochloride.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cevimeline?: 1 other product NDC are listed under this name. See all Cevimeline NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cevimeline NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cevimelinecevimeline hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Bionpharma Inc	69452-316	69452-0316-20

Other NDCs under NDA 020989

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

FDA NDC Directory listings under NDA 020989
Product	Strength	Form · route	Labeler	Product NDC
Evoxaccevimeline hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Cosette Pharmaceuticals, Inc.	0713-0883
cevimeline hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Cosette Pharmaceuticals, Inc.	0713-0937
cevimeline hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-3168