Prescription drug · ANDA
Primidone NDC 65162-545
Primidone 250 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-545-10 | 6516205451065162054510 | 100 TABLET in 1 BOTTLE (65162-545-10)Marketed from Dec 24, 2009 | |
| 65162-545-11 | 6516205451165162054511 | 1000 TABLET in 1 BOTTLE (65162-545-11)Marketed from Dec 24, 2009 | |
| 65162-545-50 | 6516205455065162054550 | 500 TABLET in 1 BOTTLE (65162-545-50)Marketed from Dec 24, 2009 |
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
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040866
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 65162-545_fe35e838-40df-42c2-bcbf-0ed9aa7eaa5bSPL ID fe35e838-40df-42c2-bcbf-0ed9aa7eaa5bSPL set ID 02ba0182-0870-4c0d-a814-a1dc427d47b8RxCUI 96304, 198150UNII 13AFD7670QUPC 0365162545104
- 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
N465162054510followed by a unit qualifier and the quantityPackage 65162-0545-10. 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, are 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 65162-545
- What is NDC 65162-545?
- 65162-545 is the product NDC for Primidone, Primidone 250 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 3 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?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 | Advagen Pharma Limited | 72888-160 | 72888-0160-0072888-0160-0172888-0160-05+1 more |
| 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 |
Other NDCs under ANDA 040866
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 250 mg/1 | TabletOral | AvPAK | 50268-687 |
| Primidone | Primidone 50 mg/1 | TabletOral | AvPAK | 50268-686 |
| Primidone | Primidone 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7811 |
| Primidone | Primidone 50 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-544 |
| Primidone | Primidone 250 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-545 |
| Primidone | Primidone 50 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8206 |
| Primidone | Primidone 50 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-544 |
| Primidone | Primidone 50 mg/1 | TabletOral | AvKARE | 42291-509 |
| Primidone | Primidone 250 mg/1 | TabletOral | AvKARE | 42291-511 |