Primidone
- Product NDC
- 65162-545
- 11-digit product format
- 651620545
- Labeler code
- 65162
- Product ID
- 65162-545_fe35e838-40df-42c2-bcbf-0ed9aa7eaa5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA040866
- Marketing category
- ANDA
- Marketing start
- 2009-12-24
- Substance
- PRIMIDONE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Primidone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRIMIDONE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 13AFD7670Q |
| Rxcui | 96304, 198150 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-545-10 | Primidone | 100 in 1 BOTTLE | TABLET | 100 | | 22 |
| 65162-545-11 | Primidone | 1000 in 1 BOTTLE | TABLET | 1000 | | 22 |
| 65162-545-50 | Primidone | 500 in 1 BOTTLE | TABLET | 500 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PRIMIDONE | ACTIVE INGREDIENT | 13AFD7670Q | PRIMIDONE TABLET [AMNEAL PHARMACEUTICALS] | 10 | |
| PRIMIDONE | ACTIVE MOIETY | 13AFD7670Q | PRIMIDONE TABLET [AMNEAL PHARMACEUTICALS] | 10 | |
| PRIMIDONE | ACTIVE INGREDIENT | 13AFD7670Q | PRIMIDONE (PRIMIDONE) TABLET [AVKARE, INC.] | 5 | |
| PRIMIDONE | ACTIVE MOIETY | 13AFD7670Q | PRIMIDONE (PRIMIDONE) TABLET [AVKARE, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRIMIDONE (PRIMIDONE) TABLET [AVKARE, INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PRIMIDONE (PRIMIDONE) TABLET [AVKARE, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRIMIDONE (PRIMIDONE) TABLET [AVKARE, INC.] | 5 | |
| METHYLCELLULOSE (100 CPS) | INACTIVE INGREDIENT | 4GFU244C4J | PRIMIDONE (PRIMIDONE) TABLET [AVKARE, INC.] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | PRIMIDONE (PRIMIDONE) TABLET [AVKARE, INC.] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PRIMIDONE (PRIMIDONE) TABLET [AVKARE, INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PRIMIDONE (PRIMIDONE) TABLET [AVKARE, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-545 | PRIMIDONE TABLET [AMNEAL PHARMACEUTICALS LLC] | 22 | Current NDC, Legacy NDC, 3 package rows | 20241031_02ba0182-0870-4c0d-a814-a1dc427d47b8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-545-10 | 65162054510 | 100 TABLET in 1 BOTTLE (65162-545-10) | 100 tablet | 2009-12-24 | 0000-00-00 | No | No | Current |
| 65162-545-11 | 65162054511 | 1000 TABLET in 1 BOTTLE (65162-545-11) | 1000 tablet | 2009-12-24 | 0000-00-00 | No | No | Current |
| 65162-545-50 | 65162054550 | 500 TABLET in 1 BOTTLE (65162-545-50) | 500 tablet | 2009-12-24 | 0000-00-00 | No | No | Current |