Prescription drug · ANDA
Primidone NDC 0527-1301
Primidone 50 mg/1 · Tablet · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-1301-01 | 00527130101 | 100 TABLET in 1 BOTTLE (0527-1301-01)Marketed from May 24, 2001 | |
| 0527-1301-05 | 00527130105 | 500 TABLET in 1 BOTTLE (0527-1301-05)Marketed from May 24, 2001 | |
| 0527-1301-10 | 00527130110 | 1000 TABLET in 1 BOTTLE (0527-1301-10)Marketed from May 24, 2001 |
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
- Labeler
- Lannett Company, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 084903
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0527-1301_99bd0a67-2742-43dd-9ddc-430b9141c3b1SPL ID 99bd0a67-2742-43dd-9ddc-430b9141c3b1SPL set ID a1a817f7-c190-4825-94eb-442f477187e3RxCUI 96304, 198150UNII 13AFD7670QUPC 0305871231011
- 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
N400527130101followed by a unit qualifier and the quantityPackage 00527-1301-01. 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
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 084903
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 | Chartwell RX, LLC | 62135-468 |
| Primidone | Primidone 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-763 |
| Primidone | Primidone 50 mg/1 | TabletOral | American Health Packaging | 68084-202 |
| Primidone | Primidone 250 mg/1 | TabletOral | American Health Packaging | 68084-203 |
| Primidone | Primidone 50 mg/1 | TabletOral | Golden State Medical Supply, Inc | 51407-637 |
| Primidone | Primidone 250 mg/1 | TabletOral | Golden State Medical Supply, Inc | 51407-638 |
| Primidone | Primidone 250 mg/1 | TabletOral | Lannett Company, Inc. | 0527-1231 |