Primidone
- Product NDC
- 0615-8206
- 11-digit product format
- 006158206
- Labeler code
- 0615
- Product ID
- 0615-8206_f55d60a8-a938-4bbf-9410-87107696ad16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA040866
- Marketing category
- ANDA
- Marketing start
- 2009-12-24
- 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 |
|---|
| 0615-8206-30 | Primidone | 5 in 1 BLISTER PACK | TABLET | 5 | | 3 |
| 0615-8206-30 | Primidone | 6 in 1 BOX, UNIT-DOSE | TABLET | 6 | | 3 |
| 0615-8206-39 | Primidone | 30 in 1 BLISTER PACK | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8206 | PRIMIDONE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 3 | Current NDC, Legacy NDC, 3 package rows | 20230306_1c56d09c-4224-4875-bb22-e8bfd595d378.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 |
|---|
| 0615-8206-30 | 00615820630 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8206-30) > 5 TABLET in 1 BLISTER PACK | 6 blister pack | 2018-04-12 | 0000-00-00 | No | No | Current |
| 0615-8206-39 | 00615820639 | 30 TABLET in 1 BLISTER PACK (0615-8206-39) | 30 tablet | 2018-04-05 | 0000-00-00 | No | No | Current |