Prescription drug · ANDA
Cevimeline Hydrochloride NDC 72162-2563
Cevimeline hydrochloride 30 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2563-1 | 72162256301 | 100 CAPSULE in 1 BOTTLE (72162-2563-1)Marketed from Nov 4, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch PrepackNDC labeler code 72162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215056
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Agonists (Mechanism)
- Identifiers
- Product ID 72162-2563_fb360aef-a237-424f-95a0-f39d33113bd7SPL ID fb360aef-a237-424f-95a0-f39d33113bd7SPL set ID 71ada1b0-3344-4202-9277-57f1a37402c1RxCUI 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
N472162256301followed by a unit qualifier and the quantityPackage 72162-2563-01. 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 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 72162-2563
- What is NDC 72162-2563?
- 72162-2563 is the product NDC for Cevimeline Hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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?
- Bryant Ranch Prepack, NDC labeler code 72162. 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?
- 16 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 | 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 | 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 |
| cevimeline hydrochloride | Cevimeline hydrochloride 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3168 | 71335-3168-0171335-3168-0271335-3168-03 |
| cevimeline hydrochloride | Cevimeline hydrochloride 30 mg/1 | CapsuleOral | Novel Laboratories, Inc. | 40032-999 | 40032-0999-0140032-0999-0340032-0999-05 |
Other NDCs under ANDA 215056
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 | Aurobindo Pharma Limited | 59651-422 |