Prescription drug · NDA
cevimeline hydrochloride NDC 87063-324
Cevimeline hydrochloride 30 mg/1 · Capsule · Oral · ASCLEMED USA INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 87063-324-01 | 8706303240187063032401 | 100 CAPSULE in 1 BOTTLE, PLASTIC (87063-324-01)Marketed from Oct 2, 2026 | |
| 87063-324-10 | 8706303241087063032410 | 10 CAPSULE in 1 BOTTLE, PLASTIC (87063-324-10)Marketed from Oct 2, 2026 | |
| 87063-324-20 | 8706303242087063032420 | 20 CAPSULE in 1 BOTTLE, PLASTIC (87063-324-20)Marketed from Oct 2, 2026 | |
| 87063-324-30 | 8706303243087063032430 | 30 CAPSULE in 1 BOTTLE, PLASTIC (87063-324-30)Marketed from Oct 2, 2026 | |
| 87063-324-60 | 8706303246087063032460 | 60 CAPSULE in 1 BOTTLE, PLASTIC (87063-324-60)Marketed from Oct 2, 2026 | |
| 87063-324-90 | 8706303249087063032490 | 90 CAPSULE in 1 BOTTLE, PLASTIC (87063-324-90)Marketed from Oct 2, 2026 |
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
- ASCLEMED USA INC.NDC labeler code 87063
- 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 87063-324_5cd4fae1-8224-eee2-e063-6294a90a689eSPL ID 5cd4fae1-8224-eee2-e063-6294a90a689e
- 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
N487063032401followed by a unit qualifier and the quantityPackage 87063-0324-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 87063-324
- What is NDC 87063-324?
- 87063-324 is the product NDC for cevimeline hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by ASCLEMED USA INC.. It has 6 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?
- ASCLEMED USA INC., NDC labeler code 87063. 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.
Related NDCs: other cevimeline hydrochloride 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 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 | Aurobindo Pharma Limited | 59651-422 | 59651-0422-0159651-0422-05 |
| 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 |
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 |
|---|---|---|---|---|
| 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 |
| Evoxaccevimeline hydrochloride | Cevimeline hydrochloride 30 mg/1 | CapsuleOral | Cosette Pharmaceuticals, Inc. | 0713-0883 |