Prescription drug · NDA
cevimeline hydrochloride NDC 0713-0937
Cevimeline hydrochloride 30 mg/1 · Capsule · Oral · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0937-01 | 00713093701 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0937-01)Marketed from Jan 3, 2023 |
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)
- cevimeline hydrochloride
- Generic name (nonproprietary)
- cevimeline hydrochloride
- Active ingredients
- Cevimeline hydrochloride — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020989
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Agonists (Mechanism)
- Identifiers
- Product ID 0713-0937_f183f958-57f5-ea10-e053-2995a90a5eadSPL ID f183f958-57f5-ea10-e053-2995a90a5eadSPL set ID efc2bb24-4dda-4781-bef5-fcd9abf082ddRxCUI 309140UNII P81Q6V85NPUPC 0307130937016
- 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
N400713093701followed by a unit qualifier and the quantityPackage 00713-0937-01. 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 .
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.
Other NDCs under NDA 020989
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | Bryant Ranch Prepack | 71335-3168 |
| Cevimeline | Cevimeline hydrochloride 30 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 63304-479 |