Prescription drug · NDA
Mysoline (Primidone) NDC 66490-690
Primidone 50 mg/1 · Tablet · Oral · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66490-690-10 | 6649006901066490069010 | 100 TABLET in 1 BOTTLE (66490-690-10)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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bausch Health US, LLCNDC labeler code 66490
- 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 66490-690_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
N466490069010followed by a unit qualifier and the quantityPackage 66490-0690-10. 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.
About NDC 66490-690
- What is NDC 66490-690?
- 66490-690 is the product NDC for Mysoline (primidone), Primidone 50 mg/1 tablet, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mysoline (Primidone).
- What is the active ingredient?
- Primidone.
- Who is the labeler?
- Bausch Health US, LLC, NDC labeler code 66490. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mysoline?
- 1 other product NDC are listed under this name. See all Mysoline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mysoline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mysolineprimidone | Primidone 250 mg/1 | TabletOral | Bausch Health US, LLC | 66490-691 | 66490-0691-10 |
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 250 mg/1 | TabletOral | Bausch Health US, LLC | 66490-691 |