Prescription drug · ANDA
Primidone NDC 51407-637
Primidone 50 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-637-01 | 51407063701 | 100 TABLET in 1 BOTTLE (51407-637-01)Marketed from Feb 3, 2022 | |
| 51407-637-05 | 51407063705 | 500 TABLET in 1 BOTTLE (51407-637-05)Marketed from Feb 3, 2022 |
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 084903
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 51407-637_29f49f7f-d100-e0e1-e063-6394a90ac981SPL ID 29f49f7f-d100-e0e1-e063-6394a90ac981SPL set ID e4e493bd-94d7-7e5a-e053-2995a90a2706RxCUI 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
N451407063701followed by a unit qualifier and the quantityPackage 51407-0637-01. 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 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 250 mg/1 | TabletOral | Golden State Medical Supply, Inc | 51407-638 |
| Primidone | Primidone 250 mg/1 | TabletOral | Lannett Company, Inc. | 0527-1231 |
| Primidone | Primidone 50 mg/1 | TabletOral | Lannett Company, Inc. | 0527-1301 |