Primidone
- Product NDC
- 0527-1301
- 11-digit product format
- 005271301
- Labeler code
- 0527
- Product ID
- 0527-1301_99bd0a67-2742-43dd-9ddc-430b9141c3b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA084903
- Marketing category
- ANDA
- Marketing start
- 2001-05-24
- 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 | 96304, 198150 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0527-1301-01 | Primidone | 100 in 1 BOTTLE | TABLET | 100 | | 14 |
| 0527-1301-05 | Primidone | 500 in 1 BOTTLE | TABLET | 500 | | 14 |
| 0527-1301-10 | Primidone | 1000 in 1 BOTTLE | TABLET | 1000 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PRIMIDONE | ACTIVE INGREDIENT | 13AFD7670Q | PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 9 | |
| PRIMIDONE | ACTIVE MOIETY | 13AFD7670Q | PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 9 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 9 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 9 | |
| METHYLCELLULOSE (400 CPS) | INACTIVE INGREDIENT | O0GN6F9B2Y | PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 9 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 9 | |
| PRIMIDONE | ACTIVE INGREDIENT | 13AFD7670Q | PRIMIDONE TABLET [LANNETT COMPANY, INC.] | 6 | |
| PRIMIDONE | ACTIVE MOIETY | 13AFD7670Q | PRIMIDONE TABLET [LANNETT COMPANY, INC.] | 6 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | PRIMIDONE TABLET [LANNETT COMPANY, INC.] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PRIMIDONE TABLET [LANNETT COMPANY, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRIMIDONE TABLET [LANNETT COMPANY, INC.] | 6 | |
| METHYLCELLULOSE (400 CPS) | INACTIVE INGREDIENT | O0GN6F9B2Y | PRIMIDONE TABLET [LANNETT COMPANY, INC.] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PRIMIDONE TABLET [LANNETT COMPANY, INC.] | 6 | |
| PRIMIDONE | ACTIVE INGREDIENT | 13AFD7670Q | PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING] | 2 | |
| PRIMIDONE | ACTIVE MOIETY | 13AFD7670Q | PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING] | 2 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING] | 2 | |
| METHYLCELLULOSE (400 MPA.S) | INACTIVE INGREDIENT | O0GN6F9B2Y | PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING] | 2 | |
| PRIMIDONE | ACTIVE INGREDIENT | 13AFD7670Q | PRIMIDONE TABLET [STAT RX USA LLC] | 1 | |
| PRIMIDONE | ACTIVE MOIETY | 13AFD7670Q | PRIMIDONE TABLET [STAT RX USA LLC] | 1 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | PRIMIDONE TABLET [STAT RX USA LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PRIMIDONE TABLET [STAT RX USA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRIMIDONE TABLET [STAT RX USA LLC] | 1 | |
| METHYLCELLULOSE (400 CPS) | INACTIVE INGREDIENT | O0GN6F9B2Y | PRIMIDONE TABLET [STAT RX USA LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PRIMIDONE TABLET [STAT RX USA LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-1301 | PRIMIDONE TABLET [LANNETT COMPANY, INC.] | 14 | Current NDC, Legacy NDC, 3 package rows | 20240704_a1a817f7-c190-4825-94eb-442f477187e3.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 |
|---|
| 0527-1301-01 | 00527130101 | 100 TABLET in 1 BOTTLE (0527-1301-01) | 100 tablet | 2001-05-24 | 0000-00-00 | No | No | Current |
| 0527-1301-05 | 00527130105 | 500 TABLET in 1 BOTTLE (0527-1301-05) | 500 tablet | 2001-05-24 | 0000-00-00 | No | No | Current |
| 0527-1301-10 | 00527130110 | 1000 TABLET in 1 BOTTLE (0527-1301-10) | 1000 tablet | 2001-05-24 | 0000-00-00 | No | No | Current |