Primidone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Primidone.
| Product ID | 71610-191_5342e071-7b2f-4231-a73d-8c227f928494 |
| NDC | 71610-191 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Primidone |
| Generic Name | Primidone |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2005-04-07 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA084903 |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| Substance Name | PRIMIDONE |
| Active Ingredient Strength | 50 mg/1 |
| Pharm Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2018-11-09 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA084903 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-11-09 |
| Ingredient | Strength |
|---|---|
| PRIMIDONE | 50 mg/1 |
| SPL SET ID: | fe761fa9-d97c-4ef4-a816-96e237c8749c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-1482 | Primidone | Primidone |
| 0143-1484 | Primidone | Primidone |
| 0527-1231 | Primidone | Primidone |
| 0527-1301 | Primidone | Primidone |
| 0591-5321 | Primidone | Primidone |
| 0603-5371 | Primidone | primidone |
| 0603-5372 | Primidone | primidone |
| 0615-2521 | Primidone | primidone |
| 0615-5591 | Primidone | Primidone |
| 0615-7738 | Primidone | Primidone |
| 0615-7936 | Primidone | primidone |
| 0615-8206 | Primidone | Primidone |
| 0904-5559 | Primidone | Primidone |
| 10135-522 | Primidone | Primidone |
| 10135-540 | Primidone | Primidone |
| 42291-508 | Primidone | primidone |
| 42291-509 | Primidone | Primidone |
| 42291-511 | Primidone | Primidone |
| 50090-1622 | Primidone | Primidone |
| 50090-1636 | Primidone | Primidone |
| 50090-4083 | Primidone | Primidone |
| 50268-686 | Primidone | Primidone |
| 50268-687 | Primidone | Primidone |
| 51407-637 | Primidone | Primidone |
| 51407-638 | Primidone | Primidone |
| 53746-544 | Primidone | Primidone |
| 68084-203 | Primidone | Primidone |
| 68084-202 | Primidone | Primidone |
| 68682-690 | Primidone | Primidone |
| 68682-691 | Primidone | Primidone |
| 71610-191 | Primidone | Primidone |
| 71610-005 | Primidone | Primidone |
| 71610-079 | Primidone | Primidone |
| 53746-545 | Primidone | Primidone |
| 55111-477 | Primidone | Primidone |
| 55111-476 | Primidone | Primidone |
| 63629-7811 | Primidone | Primidone |
| 65162-544 | Primidone | Primidone |
| 65162-545 | Primidone | Primidone |
| 71335-1158 | Primidone | Primidone |