Prescription drug · NDA
Salagen (pilocarpine hydrochloride) NDC 59212-775
Pilocarpine hydrochloride 7.5 mg/1 · Tablet, Film coated · Oral · Advanz Pharma (US) Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59212-775-10 | 59212077510 | 100 TABLET, FILM COATED in 1 BOTTLE (59212-775-10)Marketed from Sep 1, 2019 |
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)
- Salagen
- Generic name (nonproprietary)
- pilocarpine hydrochloride
- Active ingredients
- Pilocarpine hydrochloride — 7.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Advanz Pharma (US) Corp.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020237
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Agonists (Mechanism)Cholinergic Muscarinic Agonists (Mechanism)
- Identifiers
- Product ID 59212-775_5e2a19b9-0694-43ac-9e0e-b40048495a1bSPL ID 5e2a19b9-0694-43ac-9e0e-b40048495a1bSPL set ID 62eda83d-d043-4c7e-8fcf-75d05efbf35bRxCUI 1000913, 1000915, 1001004, 1001006UNII 0WW6D218XJ
- 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
N459212077510followed by a unit qualifier and the quantityPackage 59212-0775-10. 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 & USAGE SALAGEN ® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020237
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 |
|---|---|---|---|---|
| Pilocarpine hydrochloride | Pilocarpine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Actavis Pharma, Inc. | 0228-2837 |
| Pilocarpine hydrochloride | Pilocarpine hydrochloride 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-928 |
| Salagenpilocarpine hydrochloride | Pilocarpine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Advanz Pharma (US) Corp. | 59212-705 |
| Pilocarpine hydrochloride | Pilocarpine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Actavis Pharma, Inc. | 0228-2801 |