Primidone
- Product NDC
- 71335-1965
- 11-digit product format
- 713351965
- Labeler code
- 71335
- Product ID
- 71335-1965_5f5bb283-9a75-49c5-8537-9cd1270c22ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 | 198150 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1965-1 | Primidone | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 103 |
| 71335-1965-2 | Primidone | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 103 |
| 71335-1965-3 | Primidone | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1965 | PRIMIDONE TABLET [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 3 package rows | 20240524_5067ff85-07f5-424c-b072-6907891e7b4e.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 |
|---|
| 71335-1965-1 | 71335196501 | 30 TABLET in 1 BOTTLE, PLASTIC (71335-1965-1) | 30 tablet | 2022-05-03 | 0000-00-00 | No | No | Current |
| 71335-1965-2 | 71335196502 | 90 TABLET in 1 BOTTLE, PLASTIC (71335-1965-2) | 90 tablet | 2021-10-04 | 0000-00-00 | No | No | Current |
| 71335-1965-3 | 71335196503 | 60 TABLET in 1 BOTTLE, PLASTIC (71335-1965-3) | 60 tablet | 2022-05-03 | 0000-00-00 | No | No | Current |