Prescription drug · ANDA
Primidone NDC 0615-8206
Primidone 50 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8206-39 | 00615820639 | 30 TABLET in 1 BLISTER PACK (0615-8206-39)Marketed from Apr 5, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Primidone
- Generic name (nonproprietary)
- primidone
- Active ingredients
- Primidone — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040866
- Marketing start
- Marketing end
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0615-8206_93dbaa1a-4b78-4c4d-a017-36d9736a4145SPL ID 93dbaa1a-4b78-4c4d-a017-36d9736a4145SPL set ID 1c56d09c-4224-4875-bb22-e8bfd595d378RxCUI 198150UNII 13AFD7670Q
- 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
N400615820639followed by a unit qualifier and the quantityPackage 00615-8206-39. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 040866
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 |
|---|---|---|---|---|
| Primidone | Primidone 50 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-544 |
| Primidone | Primidone 250 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-545 |
| Primidone | Primidone 50 mg/1 | TabletOral | AvPAK | 50268-686 |
| Primidone | Primidone 250 mg/1 | TabletOral | AvPAK | 50268-687 |
| Primidone | Primidone 50 mg/1 | TabletOral | AvKARE | 42291-509 |
| Primidone | Primidone 250 mg/1 | TabletOral | AvKARE | 42291-511 |
| Primidone | Primidone 50 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-544 |
| Primidone | Primidone 250 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-545 |
| Primidone | Primidone 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7811 |