Primidone
- Product NDC
- 0591-5321
- 11-digit product format
- 005915321
- Labeler code
- 0591
- Product ID
- 0591-5321_dc55f802-2977-4761-b1c5-179c1bd7a336
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA083551
- Marketing category
- ANDA
- Marketing start
- 2010-06-19
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-5321-01 | Primidone | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PRIMIDONE | ACTIVE INGREDIENT | 13AFD7670Q | PRIMIDONE TABLET [WATSON LABORATORIES, INC.] | 13 | |
| PRIMIDONE | ACTIVE MOIETY | 13AFD7670Q | PRIMIDONE TABLET [WATSON LABORATORIES, INC.] | 13 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRIMIDONE TABLET [WATSON LABORATORIES, INC.] | 13 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PRIMIDONE TABLET [WATSON LABORATORIES, INC.] | 13 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | PRIMIDONE TABLET [WATSON LABORATORIES, INC.] | 13 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRIMIDONE TABLET [WATSON LABORATORIES, INC.] | 13 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | PRIMIDONE TABLET [WATSON LABORATORIES, INC.] | 13 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PRIMIDONE TABLET [WATSON LABORATORIES, INC.] | 13 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | PRIMIDONE TABLET [WATSON LABORATORIES, INC.] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-5321 | PRIMIDONE TABLET [ACTAVIS PHARMA, INC.] | 19 | Current NDC, Legacy NDC, 1 package rows | 20250319_ae0fa704-818e-4423-8e3a-6cc3390cdd7d.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 |
|---|
| 0591-5321-01 | 00591532101 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-5321-01) | 100 tablet | 2010-06-19 | 0000-00-00 | No | No | Current |
| 0591-5321-10 | 00591532110 | 1000 TABLET in 1 BOTTLE, PLASTIC (0591-5321-10) | 1000 tablet | 2010-06-19 | 0000-00-00 | No | No | Current |