Primidone
- Product NDC
- 10135-522
- 11-digit product format
- 101350522
- Labeler code
- 10135
- Product ID
- 10135-522_ba71937b-a7fc-28c5-e053-2995a90a2000
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA084903
- Marketing category
- ANDA
- Marketing start
- 2015-05-01
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3a6e0ba9-1dda-c47a-a8e3-5844e445a4f8 | Product name | 3 | 20250114 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10135-522-01 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2027-a910-e053-dadaa90a0b85 | Primidone |
| 10135-522-05 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2027-a910-e053-dadaa90a0b85 | Primidone |
| 10135-522-10 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2027-a910-e053-dadaa90a0b85 | Primidone |
| 10135-522-01 | 2021-02-03 | C162847 | 48780-1 | ba0f9c33-2027-a910-e053-dadaa90a0b85 | Primidone |
| 10135-522-05 | 2021-02-03 | C162847 | 48780-1 | ba0f9c33-2027-a910-e053-dadaa90a0b85 | Primidone |
| 10135-522-10 | 2021-02-03 | C162847 | 48780-1 | ba0f9c33-2027-a910-e053-dadaa90a0b85 | Primidone |
| 10135-522-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2027-a910-e053-dadaa90a0b85 | Primidone |
| 10135-522-05 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2027-a910-e053-dadaa90a0b85 | Primidone |
| 10135-522-10 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2027-a910-e053-dadaa90a0b85 | Primidone |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10135-522-01 | Primidone | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 10135-522-05 | Primidone | 500 in 1 BOTTLE | TABLET | 500 | 3 | |
| 10135-522-10 | Primidone | 1000 in 1 BOTTLE | TABLET | 1000 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10135-522-01 | EA - Each | 10135-522 | 67ec3627-2281-42be-9982-2db5860bd766 | 1 | 2015-06-09 |
| 10135-522-05 | EA - Each | 10135-522 | d117193a-d81f-47e3-85a7-dddea827f2ed | 1 | 2015-06-09 |
| 10135-522-10 | EA - Each | 10135-522 | 195341d1-a2e6-40bc-ac15-88f51085aca6 | 1 | 2015-06-09 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PRIMIDONE | ACTIVE INGREDIENT | 13AFD7670Q | PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| PRIMIDONE | ACTIVE MOIETY | 13AFD7670Q | PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| METHYLCELLULOSE (400 MPA.S) | INACTIVE INGREDIENT | O0GN6F9B2Y | PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 96304 | primidone 250 MG Oral Tablet | PSN | 934a6d96-6da2-4fba-bf1f-08e7acbf59bc | 3 |
| 198150 | primidone 50 MG Oral Tablet | PSN | 934a6d96-6da2-4fba-bf1f-08e7acbf59bc | 3 |
| 96304 | primidone 250 MG Oral Tablet | SCD | 934a6d96-6da2-4fba-bf1f-08e7acbf59bc | 3 |
| 198150 | primidone 50 MG Oral Tablet | SCD | 934a6d96-6da2-4fba-bf1f-08e7acbf59bc | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10135-522-01 | 10135052201 | 100 TABLET in 1 BOTTLE (10135-522-01) | 100 tablet | 2015-05-01 | 0000-00-00 | No | No | Current |
| 10135-522-05 | 10135052205 | 500 TABLET in 1 BOTTLE (10135-522-05) | 500 tablet | 2015-05-01 | 0000-00-00 | No | No | Current |
| 10135-522-10 | 10135052210 | 1000 TABLET in 1 BOTTLE (10135-522-10) | 1000 tablet | 2015-05-01 | 0000-00-00 | No | No | Current |