Prescription drug · ANDA
Primidone NDC 53746-545
Primidone 250 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53746-545-01 | 53746054501 | 100 TABLET in 1 BOTTLE (53746-545-01)Marketed from Dec 24, 2009 | |
| 53746-545-05 | 53746054505 | 500 TABLET in 1 BOTTLE (53746-545-05)Marketed from Dec 24, 2009 | |
| 53746-545-10 | 53746054510 | 1000 TABLET in 1 BOTTLE (53746-545-10)Marketed from Dec 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)
- Primidone
- Generic name (nonproprietary)
- primidone
- Active ingredients
- Primidone — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040866
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 53746-545_574c0bff-04c5-41f0-8d10-315a824d8efdSPL ID 574c0bff-04c5-41f0-8d10-315a824d8efdSPL set ID 3cdc361a-5558-4341-ad40-f8bc29b4f1ceRxCUI 96304, 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
N453746054501followed by a unit qualifier and the quantityPackage 53746-0545-01. 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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8206 |
| 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 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7811 |