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NDC 65162-0544-11 Primidone 50 mg/1 Details
Primidone 50 mg/1
Primidone is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is PRIMIDONE.
MedlinePlus Drug Summary
Primidone is used alone or with other medications to control certain types of seizures. Primidone is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Related Packages: 65162-0544-11Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Primidone
Product Information
| NDC | 65162-0544 |
|---|---|
| Product ID | 65162-544_8e3d05bf-88ed-441c-8917-884a262ce040 |
| Associated GPIs | 72600060000305 |
| GCN Sequence Number | 004544 |
| GCN Sequence Number Description | primidone TABLET 50 MG ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 17322 |
| HICL Sequence Number | 001886 |
| HICL Sequence Number Description | PRIMIDONE |
| Brand/Generic | Generic |
| Proprietary Name | Primidone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Primidone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | PRIMIDONE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA040866 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0544-11 (65162054411)
| NDC Package Code | 65162-544-11 |
|---|---|
| Billing NDC | 65162054411 |
| Package | 1000 TABLET in 1 BOTTLE (65162-544-11) |
| Marketing Start Date | 2009-12-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |