Prescription drug · ANDA
Cevimeline (Cevimeline hydrochloride) NDC 69452-316
Cevimeline hydrochloride 30 mg/1 · Capsule · Oral · Bionpharma Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-316-20 | 6945203162069452031620 | 100 CAPSULE in 1 BOTTLE (69452-316-20)Marketed from Jan 17, 2024 |
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
- Generic name (nonproprietary)
- cevimeline hydrochloride
- Active ingredients
- Cevimeline hydrochloride — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bionpharma IncNDC labeler code 69452
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218290
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Agonists (Mechanism)
- Identifiers
- Product ID 69452-316_10e26216-a6d9-ab89-e063-6294a90a298cSPL ID 10e26216-a6d9-ab89-e063-6294a90a298cSPL set ID 0f15cb50-5917-c928-e063-6294a90ab284RxCUI 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
N469452031620followed by a unit qualifier and the quantityPackage 69452-0316-20. 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 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.
About NDC 69452-316
- What is NDC 69452-316?
- 69452-316 is the product NDC for Cevimeline (cevimeline hydrochloride), Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Bionpharma Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cevimeline (Cevimeline hydrochloride).
- What is the active ingredient?
- Cevimeline hydrochloride.
- Who is the labeler?
- Bionpharma Inc, NDC labeler code 69452. 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?
- 1 other product NDC are listed under this name. See all Cevimeline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cevimeline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cevimeline | Cevimeline hydrochloride 30 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 63304-479 | 63304-0479-01 |