What is NDC 43386-999?

43386-999 is the product NDC for cevimeline hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Lupin Pharmaceuticals,Inc..

Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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 43386-999

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-999Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0999Add the package segment from the table below.

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: Lupin Pharmaceuticals,Inc.NDC labeler code 43386
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 43386-999_7e108db5-5292-4f2e-9d10-e15319503898SPL ID 7e108db5-5292-4f2e-9d10-e15319503898SPL set ID 0fbcf1a7-5b8b-42fb-b764-4b529e7d1a99RxCUI 309140UNII P81Q6V85NPUPC 0343386999057
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.

Product label

Current FDA label (SPL), effective Jan 30, 2024.

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 43386-999

What is NDC 43386-999?: 43386-999 is the product NDC for cevimeline hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Lupin Pharmaceuticals,Inc..
What drug is associated with this NDC?: cevimeline hydrochloride.
What is the active ingredient?: Cevimeline hydrochloride.
Who is the labeler?: Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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	Macleods Pharmaceuticals Limited	33342-216	33342-0216-11
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2563	72162-2563-01
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	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	71335-2326	71335-2326-0171335-2326-0271335-2326-03
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

All 17 cevimeline hydrochloride NDCs

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	Novel Laboratories, Inc.	40032-999