Prescription drug · ANDA
Primidone NDC 72189-216
Primidone 50 mg/1 · Tablet · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-216-60 | 72189021660 | 60 TABLET in 1 BOTTLE (72189-216-60)Marketed from May 11, 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
- Labeler
- DIRECT RX
- 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 72189-216_2be9877c-0b1e-23b4-e063-6394a90af68fSPL ID 2be9877c-0b1e-23b4-e063-6394a90af68fSPL set ID c20f803c-e965-9dd8-e053-2995a90a92baRxCUI 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
N472189021660followed by a unit qualifier and the quantityPackage 72189-0216-60. 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)
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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-540 |
| 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 | 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 |