What is NDC 59651-422?

59651-422 is the product NDC for Cevimeline Hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. 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?

18 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 59651-422

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-422Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0422Add 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
59651-422-01	5965104220159651042201	100 CAPSULE in 1 BOTTLE (59651-422-01)Marketed from Apr 18, 2023
59651-422-05	5965104220559651042205	500 CAPSULE in 1 BOTTLE (59651-422-05)Marketed from Apr 18, 2023

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: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215056
Marketing start: Apr 18, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 59651-422_d08d8aa5-76a4-417a-a308-7d195865522fSPL ID d08d8aa5-76a4-417a-a308-7d195865522fSPL set ID d08d8aa5-76a4-417a-a308-7d195865522fRxCUI 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

N459651042201 followed by a unit qualifier and the quantity

Package 59651-0422-01. 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 Apr 19, 2023.

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 59651-422

What is NDC 59651-422?: 59651-422 is the product NDC for Cevimeline Hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 2 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?: Aurobindo Pharma Limited, NDC labeler code 59651. 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?: 18 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	Hikma Pharmaceuticals USA Inc.	0054-0893	00054-0893-25
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	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	PD-Rx Pharmaceuticals, Inc.	72789-457	72789-0457-0172789-0457-30
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	Bryant Ranch Prepack	71335-3168	71335-3168-0171335-3168-0271335-3168-03

All 19 Cevimeline Hydrochloride NDCs

Other NDCs under ANDA 215056

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

FDA NDC Directory listings under ANDA 215056
Product	Strength	Form · route	Labeler	Product NDC
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2563