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 | 7288801600072888016000 | 1000 TABLET in 1 BOTTLE (72888-160-00)Marketed from Jun 28, 2022 | |
| 72888-160-01 | 7288801600172888016001 | 100 TABLET in 1 BOTTLE (72888-160-01)Marketed from Jun 28, 2022 | |
| 72888-160-05 | 7288801600572888016005 | 500 TABLET in 1 BOTTLE (72888-160-05)Marketed from Jun 28, 2022 | |
| 72888-160-30 | 7288801603072888016030 | 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 LimitedNDC labeler code 72888
- 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
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.
About NDC 72888-160
- What is NDC 72888-160?
- 72888-160 is the product NDC for Primidone, Primidone 125 mg/1 tablet, listed with the FDA by Advagen Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Primidone.
- What is the active ingredient?
- Primidone.
- Who is the labeler?
- Advagen Pharma Limited, NDC labeler code 72888. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Primidone?
- 41 other product NDCs are listed under this name. See all Primidone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Primidone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Primidone | Primidone 50 mg/1 | TabletOral | NorthStar Rx LLC | 72603-609 | 72603-0609-0172603-0609-02 |
| Primidone | Primidone 250 mg/1 | TabletOral | NorthStar Rx LLC | 72603-610 | 72603-0610-01 |
| Primidone | Primidone 50 mg/1 | TabletOral | Carnegie Pharmaceuticals LLC | 80005-117 | 80005-0117-1180005-0117-1480005-0117-15 |
| Primidone | Primidone 250 mg/1 | TabletOral | Carnegie Pharmaceuticals LLC | 80005-118 | 80005-0118-1180005-0118-1480005-0118-15 |
| Primidone | Primidone 50 mg/1 | TabletOral | Advagen Pharma Limited | 72888-045 | 72888-0045-0172888-0045-05 |
| Primidone | Primidone 250 mg/1 | TabletOral | Advagen Pharma Limited | 72888-046 | 72888-0046-0172888-0046-05 |
| Primidone | Primidone 125 mg/1 | TabletOral | TruPharma LLC. | 52817-117 | 52817-0117-1052817-0117-3052817-0117-50 |
| Primidone | Primidone 50 mg/1 | TabletOral | AvKARE | 42291-509 | 42291-0509-50 |
| Primidone | Primidone 250 mg/1 | TabletOral | AvKARE | 42291-511 | 42291-0511-01 |
| Primidone | Primidone 50 mg/1 | TabletOral | DIRECT RX | 72189-216 | 72189-0216-60 |
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 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 |
| Primidone | Primidone 50 mg/1 | TabletOral | Advagen Pharma Limited | 72888-045 |
| Primidone | Primidone 250 mg/1 | TabletOral | Advagen Pharma Limited | 72888-046 |