Prescription drug · NDA
Mysoline (primidone) NDC 66490-691
Primidone 250 mg/1 · Tablet · Oral · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66490-691-10 | 66490069110 | 100 TABLET in 1 BOTTLE (66490-691-10)Marketed from Jun 24, 2009 |
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)
- Mysoline
- Generic name (nonproprietary)
- primidone
- Active ingredients
- Primidone — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bausch Health US, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 009170
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 66490-691_8604870a-4144-4f14-8720-616b25257be6SPL ID 8604870a-4144-4f14-8720-616b25257be6SPL set ID af593171-dabb-4ea3-b44c-89ed457b2c46RxCUI 96304, 198150, 201747, 207478UNII 13AFD7670QUPC 0366490691105
- Pharmacologic class
- Anti-epileptic Agent
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
N466490069110followed by a unit qualifier and the quantityPackage 66490-0691-10. 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 AND USAGE MYSOLINE, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 009170
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 |
|---|---|---|---|---|
| Mysolineprimidone | Primidone 50 mg/1 | TabletOral | Bausch Health US, LLC | 66490-690 |