What is NDC 33342-216?

33342-216 is the product NDC for Cevimeline Hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 33342-216

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-216Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0216Add 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
33342-216-11	33342021611	100 CAPSULE in 1 BOTTLE (33342-216-11)Marketed from Oct 20, 2024

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: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206808
Marketing start: Oct 20, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 33342-216_67215459-3dd7-4538-9938-7d7315607fb6SPL ID 67215459-3dd7-4538-9938-7d7315607fb6SPL set ID 990887c1-11ce-4a73-83b4-0ffc5a900c85RxCUI 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

N433342021611 followed by a unit qualifier and the quantity

Package 33342-0216-11. 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 31, 2026.

Indications (excerpt from the label)

INDICATIONS & 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 33342-216

What is NDC 33342-216?: 33342-216 is the product NDC for Cevimeline Hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, 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?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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	Viona Pharmaceuticals Inc	72578-208	72578-0208-01
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1982	70771-1982-01
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	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	PD-Rx Pharmaceuticals, Inc.	72789-457	72789-0457-0172789-0457-30
cevimeline hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-3168	71335-3168-0171335-3168-0271335-3168-03
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