Prescription drug · ANDA
Primidone NDC 71610-540
Primidone 50 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-540-09 | 71610054009 | 9000 TABLET in 1 BOTTLE, PLASTIC (71610-540-09)Marketed from Jun 28, 2021 | |
| 71610-540-60 | 71610054060 | 90 TABLET in 1 BOTTLE, PLASTIC (71610-540-60)Marketed from Apr 6, 2021 | |
| 71610-540-80 | 71610054080 | 180 TABLET in 1 BOTTLE, PLASTIC (71610-540-80)Marketed from Apr 6, 2021 | |
| 71610-540-92 | 71610054092 | 270 TABLET in 1 BOTTLE, PLASTIC (71610-540-92)Marketed from Apr 6, 2021 | |
| 71610-540-94 | 71610054094 | 360 TABLET in 1 BOTTLE, PLASTIC (71610-540-94)Marketed from Sep 20, 2021 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040586
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 71610-540_11c79cec-987d-4bce-b8ce-ba3edbe60dc6SPL ID 11c79cec-987d-4bce-b8ce-ba3edbe60dc6SPL set ID 91de277e-34b8-4ee1-8846-f02aea626089RxCUI 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
N471610054009followed by a unit qualifier and the quantityPackage 71610-0540-09. 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 Primidone, 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 ANDA 040586
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 250 mg/1 | TabletOral | Proficient Rx LP | 82804-953 |
| Primidone | Primidone 50 mg/1 | TabletOral | Proficient Rx LP | 82804-952 |
| Primidone | Primidone 50 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8664 |
| Primidone | Primidone 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-590 |
| Primidone | Primidone 50 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-684 |
| Primidone | Primidone 250 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-685 |
| Primidone | Primidone 50 mg/1 | TabletOral | DIRECT RX | 72189-216 |
| Primidone | Primidone 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1965 |
| Primidone | Primidone 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-178 |
| Primidone | Primidone 250 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-177 |
| Primidone | Primidone 250 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-177 |
| Primidone | Primidone 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-178 |