Primidone
- Product NDC
- 69584-684
- 11-digit product format
- 695840684
- Labeler code
- 69584
- Product ID
- 69584-684_86b0848d-c247-4e50-bc01-dce7dc157605
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Oxford Pharmaceuticals, LLC
- Application
- ANDA040586
- Marketing category
- ANDA
- Marketing start
- 2021-02-22
- Substance
- PRIMIDONE
- Active strength
- 50 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 | 50 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 |
|---|
| 69584-684-10 | Primidone | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 4 |
| 69584-684-50 | Primidone | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69584-684 | PRIMIDONE TABLET [OXFORD PHARMACEUTICALS, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220407_439096a4-c5d5-4ad8-be9c-238973a3e290.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 |
|---|
| 69584-684-10 | 69584068410 | 100 TABLET in 1 BOTTLE, PLASTIC (69584-684-10) | 100 tablet | 2021-02-22 | 0000-00-00 | No | No | Current |
| 69584-684-50 | 69584068450 | 500 TABLET in 1 BOTTLE, PLASTIC (69584-684-50) | 500 tablet | 2021-02-22 | 0000-00-00 | No | No | Current |