Prescription drug · ANDA
Primidone NDC 80005-118
Primidone 250 mg/1 · Tablet · Oral · Carnegie Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80005-118-11 | 80005011811 | 100 TABLET in 1 BOTTLE (80005-118-11)Marketed from May 1, 2024 | |
| 80005-118-14 | 80005011814 | 500 TABLET in 1 BOTTLE (80005-118-14)Marketed from May 1, 2024 | |
| 80005-118-15 | 80005011815 | 1000 TABLET in 1 BOTTLE (80005-118-15)Marketed from May 1, 2024 |
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
- Labeler
- Carnegie Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218366
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 80005-118_1f77f842-e0b6-4659-beee-0bb01da839e3SPL ID 1f77f842-e0b6-4659-beee-0bb01da839e3SPL set ID dc018b1d-72d3-45a2-84ff-cf9499c7ae97RxCUI 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
N480005011811followed by a unit qualifier and the quantityPackage 80005-0118-11. 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 tablets, 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 218366
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 | Carnegie Pharmaceuticals LLC | 80005-117 |