Prescription drug · ANDA
Primidone NDC 72888-160
Primidone 125 mg/1 · Tablet · Oral · Advagen Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72888-160-00 | 72888016000 | 1000 TABLET in 1 BOTTLE (72888-160-00)Marketed from Jun 28, 2022 | |
| 72888-160-01 | 72888016001 | 100 TABLET in 1 BOTTLE (72888-160-01)Marketed from Jun 28, 2022 | |
| 72888-160-05 | 72888016005 | 500 TABLET in 1 BOTTLE (72888-160-05)Marketed from Jun 28, 2022 | |
| 72888-160-30 | 72888016030 | 30 TABLET in 1 BOTTLE (72888-160-30)Marketed from Jun 28, 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 — 125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advagen Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214896
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 72888-160_48453b30-812c-76c6-e063-6394a90ad9a0SPL ID 48453b30-812c-76c6-e063-6394a90ad9a0SPL set ID b3b94d2e-6a64-45b7-b0cb-0fde689240d8RxCUI 96304, 198150, 328176UNII 13AFD7670QUPC 0372888160016, 0372888046051, 0372888160009, 0372888046013, 0372888045054, 0372888160054, 0372888045016
- 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
N472888016000followed by a unit qualifier and the quantityPackage 72888-0160-00. 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 214896
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 | Advagen Pharma Limited | 72888-045 |
| Primidone | Primidone 250 mg/1 | TabletOral | Advagen Pharma Limited | 72888-046 |
| Primidone | Primidone 125 mg/1 | TabletOral | TruPharma LLC. | 52817-117 |
| Primidone | Primidone 50 mg/1 | TabletOral | NorthStar Rx LLC | 72603-609 |
| Primidone | Primidone 250 mg/1 | TabletOral | NorthStar Rx LLC | 72603-610 |