Prescription drug · ANDA
Cevimeline Hydrochloride NDC 72888-118
Cevimeline hydrochloride 30 mg/1 · Capsule · Oral · Advagen Pharma Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72888-118-00 | 7288801180072888011800 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-00)Marketed from May 3, 2023 | |
| 72888-118-01 | 7288801180172888011801 | 100 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-01)Marketed from May 3, 2023 | |
| 72888-118-05 | 7288801180572888011805 | 500 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-05)Marketed from May 3, 2023 | |
| 72888-118-30 | 7288801183072888011830 | 30 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-30)Marketed from May 3, 2023 |
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
- Advagen Pharma LtdNDC labeler code 72888
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216682
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Agonists (Mechanism)
- Identifiers
- Product ID 72888-118_473cb6cb-6b57-127c-e063-6394a90adbe8SPL ID 473cb6cb-6b57-127c-e063-6394a90adbe8SPL set ID 61dd5ee1-cf89-43ea-ada4-4e4a4d9d133bRxCUI 309140UNII P81Q6V85NPUPC 0372888118307, 0372888118055, 0372888118000, 0372888118017
- 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
N472888011800followed by a unit qualifier and the quantityPackage 72888-0118-00. 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.
About NDC 72888-118
- What is NDC 72888-118?
- 72888-118 is the product NDC for Cevimeline Hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Advagen Pharma Ltd. It has 4 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?
- Advagen Pharma Ltd, NDC labeler code 72888. 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 | 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 |
Other NDCs under ANDA 216682
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 | 71335-2326 |
| Cevimeline Hydrochloride | Cevimeline hydrochloride 30 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-457 |