What is NDC 71335-3168?

71335-3168 is the product NDC for cevimeline hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 3 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 hydrochloride?

16 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

cevimeline hydrochloride NDC 71335-3168

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-3168Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-3168Add 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
71335-3168-1	71335316801	30 CAPSULE in 1 BOTTLE (71335-3168-1)Marketed from Aug 4, 2026
71335-3168-2	71335316802	60 CAPSULE in 1 BOTTLE (71335-3168-2)Marketed from Aug 4, 2026
71335-3168-3	71335316803	90 CAPSULE in 1 BOTTLE (71335-3168-3)Marketed from Aug 4, 2026

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 PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020989
Marketing start: Jan 3, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 71335-3168_0e5763b8-0263-43fa-beaa-7828aa1d5be4SPL ID 0e5763b8-0263-43fa-beaa-7828aa1d5be4SPL set ID 7fa69ad5-7fa7-4078-9328-aacbb0d145a4RxCUI 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

N471335316801 followed by a unit qualifier and the quantity

Package 71335-3168-01. 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 Aug 4, 2026.

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)

About NDC 71335-3168

What is NDC 71335-3168?: 71335-3168 is the product NDC for cevimeline hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: cevimeline hydrochloride.
What is the active ingredient?: Cevimeline hydrochloride.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 71335. 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 hydrochloride?: 16 other product NDCs are listed under this name. See all cevimeline hydrochloride 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 hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1982	70771-1982-01
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Viona Pharmaceuticals Inc	72578-208	72578-0208-01
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Macleods Pharmaceuticals Limited	33342-216	33342-0216-11
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-422	59651-0422-0159651-0422-05
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2563	72162-2563-01
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-457	72789-0457-0172789-0457-30
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2326	71335-2326-0171335-2326-0271335-2326-03
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Advagen Pharma Ltd	72888-118	72888-0118-0072888-0118-0172888-0118-05+1 more
cevimeline hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Cosette Pharmaceuticals, Inc.	0713-0937	00713-0937-01
cevimeline hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Lupin Pharmaceuticals,Inc.	43386-999	—

All 17 cevimeline hydrochloride NDCs

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	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	63304-479