Primidone
- Product NDC
- 82804-953
- 11-digit product format
- 828040953
- Labeler code
- 82804
- Product ID
- 82804-953_db761e34-8573-4f96-872c-e851b3004e5e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040586
- Marketing category
- ANDA
- Marketing start
- 2021-02-22
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Primidone
- Listing expiration
- 2027-12-31
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 |
|---|
| 82804-953-00 | Primidone | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 1 |
| 82804-953-11 | Primidone | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 1 |
| 82804-953-30 | Primidone | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 1 |
| 82804-953-55 | Primidone | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 1 |
| 82804-953-60 | Primidone | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 1 |
| 82804-953-72 | Primidone | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 1 |
| 82804-953-90 | Primidone | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-953-00 | 82804095300 | 100 TABLET in 1 BOTTLE, PLASTIC (82804-953-00) | 100 tablet | 2026-01-12 | No | No | Current |
| 82804-953-11 | 82804095311 | 1000 TABLET in 1 BOTTLE, PLASTIC (82804-953-11) | 1000 tablet | 2026-01-12 | No | No | Current |
| 82804-953-30 | 82804095330 | 30 TABLET in 1 BOTTLE, PLASTIC (82804-953-30) | 30 tablet | 2026-01-12 | No | No | Current |
| 82804-953-55 | 82804095355 | 500 TABLET in 1 BOTTLE, PLASTIC (82804-953-55) | 500 tablet | 2026-01-12 | No | No | Current |
| 82804-953-60 | 82804095360 | 60 TABLET in 1 BOTTLE, PLASTIC (82804-953-60) | 60 tablet | 2026-01-12 | No | No | Current |
| 82804-953-72 | 82804095372 | 120 TABLET in 1 BOTTLE, PLASTIC (82804-953-72) | 120 tablet | 2026-01-12 | No | No | Current |
| 82804-953-90 | 82804095390 | 90 TABLET in 1 BOTTLE, PLASTIC (82804-953-90) | 90 tablet | 2026-01-12 | No | No | Current |