Prescription drug · ANDA
Cevimeline Hydrochloride NDC 16571-657
Cevimeline hydrochloride 30 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-657-10 | 16571065710 | 100 CAPSULE in 1 BOTTLE (16571-657-10)Marketed from Jun 17, 2014 |
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
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203775
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Agonists (Mechanism)
- Identifiers
- Product ID 16571-657_640e50a9-48ba-45e3-a3cb-c14bb313cc4fSPL ID 640e50a9-48ba-45e3-a3cb-c14bb313cc4fSPL set ID d4bd942a-1339-40c5-8fd4-850da5a69635RxCUI 309140UNII P81Q6V85NPUPC 0316571657100
- 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
N416571065710followed by a unit qualifier and the quantityPackage 16571-0657-10. 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 ANDA 203775
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 |
|---|---|---|---|---|
| Cevimeline Hydrochloride | Cevimeline hydrochloride 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9863 |
| Cevimeline Hydrochloride | Cevimeline hydrochloride 30 mg/1 | CapsuleOral | ASCLEMED USA INC. | 87063-180 |