Primidone
- Product NDC
- 53746-544
- 11-digit product format
- 537460544
- Labeler code
- 53746
- Product ID
- 53746-544_574c0bff-04c5-41f0-8d10-315a824d8efd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- 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
- 2027-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3a6e0ba9-1dda-c47a-a8e3-5844e445a4f8 | Product name | 3 | 20250114 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53746-544-01 | Primidone | 100 in 1 BOTTLE | TABLET | 100 | 11 | |
| 53746-544-05 | Primidone | 500 in 1 BOTTLE | TABLET | 500 | 11 | |
| 53746-544-10 | Primidone | 1000 in 1 BOTTLE | TABLET | 1000 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53746-544-01 | EA - Each | 53746-544 | 5a840369-eb34-482f-9ea2-e4b63c088db0 | 1 | 2017-09-11 |
| 53746-544-05 | EA - Each | 53746-544 | 8940b17e-b9d8-4c75-a960-fe9b9123d9f3 | 1 | 2017-09-11 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PRIMIDONE | ACTIVE INGREDIENT | 13AFD7670Q | PRIMIDONE TABLET [AVPAK] | 8 | |
| PRIMIDONE | ACTIVE MOIETY | 13AFD7670Q | PRIMIDONE TABLET [AVPAK] | 8 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | PRIMIDONE TABLET [AVPAK] | 8 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | PRIMIDONE TABLET [AVPAK] | 8 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | PRIMIDONE TABLET [AVPAK] | 8 | |
| Methylcellulose (100 Cps) | INACTIVE INGREDIENT | 4GFU244C4J | PRIMIDONE TABLET [AVPAK] | 8 | |
| Sodium Lauryl Sulfate | INACTIVE INGREDIENT | 368GB5141J | PRIMIDONE TABLET [AVPAK] | 8 | |
| Sodium Starch Glycolate Type A Potato | INACTIVE INGREDIENT | 5856J3G2A2 | PRIMIDONE TABLET [AVPAK] | 8 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | PRIMIDONE TABLET [AVPAK] | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 96304 | primidone 250 MG Oral Tablet | PSN | a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b | 14 |
| 198150 | primidone 50 MG Oral Tablet | PSN | a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b | 14 |
| 96304 | primidone 250 MG Oral Tablet | SCD | a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b | 14 |
| 198150 | primidone 50 MG Oral Tablet | SCD | a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b | 14 |
| 96304 | primidone 250 MG Oral Tablet | PSN | 3cdc361a-5558-4341-ad40-f8bc29b4f1ce | 11 |
| 198150 | primidone 50 MG Oral Tablet | PSN | 3cdc361a-5558-4341-ad40-f8bc29b4f1ce | 11 |
| 96304 | primidone 250 MG Oral Tablet | SCD | 3cdc361a-5558-4341-ad40-f8bc29b4f1ce | 11 |
| 198150 | primidone 50 MG Oral Tablet | SCD | 3cdc361a-5558-4341-ad40-f8bc29b4f1ce | 11 |
| 198150 | primidone 50 MG Oral Tablet | PSN | 93b4b34c-6dba-4aec-b98e-b2b18feb86a9 | 5 |
| 198150 | primidone 50 MG Oral Tablet | SCD | 93b4b34c-6dba-4aec-b98e-b2b18feb86a9 | 5 |
| 198150 | primidone 50 MG Oral Tablet | PSN | 1c56d09c-4224-4875-bb22-e8bfd595d378 | 3 |
| 198150 | primidone 50 MG Oral Tablet | SCD | 1c56d09c-4224-4875-bb22-e8bfd595d378 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53746-544-01 | 53746054401 | 100 TABLET in 1 BOTTLE (53746-544-01) | 100 tablet | 2009-12-24 | 0000-00-00 | No | No | Current |
| 53746-544-05 | 53746054405 | 500 TABLET in 1 BOTTLE (53746-544-05) | 500 tablet | 2009-12-24 | 0000-00-00 | No | No | Current |
| 53746-544-10 | 53746054410 | 1000 TABLET in 1 BOTTLE (53746-544-10) | 1000 tablet | 2009-12-24 | 0000-00-00 | No | No | Current |