What is NDC 0713-0883?

0713-0883 is the product NDC for Evoxac (cevimeline hydrochloride), Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Evoxac (Cevimeline hydrochloride).

Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Evoxac?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Evoxac NDC 0713-0883 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0883Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0883Add 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
0713-0883-01	0071308830100713088301	100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0883-01)Marketed from Sep 1, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Evoxac
Generic name (nonproprietary): cevimeline hydrochloride
Active ingredients: Cevimeline hydrochloride — 30 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020989
Marketing start: Sep 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 0713-0883_e816e1db-d4e5-425f-e053-2995a90a27c5SPL ID e816e1db-d4e5-425f-e053-2995a90a27c5SPL set ID dac32a9b-05b8-42c2-9a29-d885a9279456RxCUI 261361, 309140UNII P81Q6V85NPUPC 0307130883016
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

N400713088301 followed by a unit qualifier and the quantity

Package 00713-0883-01. 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 Sep 7, 2022.

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 0713-0883

What is NDC 0713-0883?: 0713-0883 is the product NDC for Evoxac (cevimeline hydrochloride), Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Evoxac (Cevimeline hydrochloride).
What is the active ingredient?: Cevimeline hydrochloride.
Who is the labeler?: Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Evoxac?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Cevimeline	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	63304-479
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
cevimeline hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	ASCLEMED USA INC.	87063-324

Evoxac (Cevimeline hydrochloride) NDC 0713-0883