Primidone
- Product NDC
- 55111-476
- 11-digit product format
- 551110476
- Labeler code
- 55111
- Product ID
- 55111-476_6f5c36d3-3f99-803c-5be6-66b2e1058946
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA040862
- Marketing category
- ANDA
- Marketing start
- 2008-10-03
- 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
- 2026-12-31
- 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 |
|---|---|---|---|---|---|---|
| 55111-476-01 | Primidone | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 55111-476-05 | Primidone | 500 in 1 BOTTLE | TABLET | 500 | 3 | |
| 55111-476-30 | Primidone | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 55111-476-60 | Primidone | 60 in 1 BOTTLE | TABLET | 60 | 3 | |
| 55111-476-78 | Primidone | 10 in 1 CARTON | TABLET | 10 | 3 | |
| 55111-476-79 | Primidone | 10 in 1 BLISTER PACK | TABLET | 10 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55111-476-01 | EA - Each | 55111-476 | d823aa95-5571-4058-9ae1-db4d4295856a | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| primidone | ACTIVE INGREDIENT | 13AFD7670Q | PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD] | 2 | |
| primidone | ACTIVE MOIETY | 13AFD7670Q | PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD] | 2 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD] | 2 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD] | 2 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD] | 2 | |
| sodium starch glycolate type A potato | INACTIVE INGREDIENT | 5856J3G2A2 | PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD] | 2 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD] | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 96304 | primidone 250 MG Oral Tablet | PSN | a4f917f4-2aa2-c3ed-071e-232fa0f125e8 | 3 |
| 198150 | primidone 50 MG Oral Tablet | PSN | a4f917f4-2aa2-c3ed-071e-232fa0f125e8 | 3 |
| 96304 | primidone 250 MG Oral Tablet | SCD | a4f917f4-2aa2-c3ed-071e-232fa0f125e8 | 3 |
| 198150 | primidone 50 MG Oral Tablet | SCD | a4f917f4-2aa2-c3ed-071e-232fa0f125e8 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55111-476-01 | 55111047601 | 100 TABLET in 1 BOTTLE (55111-476-01) | 100 tablet | 2008-10-03 | 0000-00-00 | No | No | Current |
| 55111-476-05 | 55111047605 | 500 TABLET in 1 BOTTLE (55111-476-05) | 500 tablet | 2008-10-03 | 0000-00-00 | No | No | Current |
| 55111-476-30 | 55111047630 | 30 TABLET in 1 BOTTLE (55111-476-30) | 30 tablet | 2008-10-03 | 0000-00-00 | No | No | Current |
| 55111-476-60 | 55111047660 | 60 TABLET in 1 BOTTLE (55111-476-60) | 60 tablet | 2008-10-03 | 0000-00-00 | No | No | Current |
| 55111-476-78 | 55111047678 | 10 BLISTER PACK in 1 CARTON (55111-476-78) / 10 TABLET in 1 BLISTER PACK (55111-476-79) | 10 blister pack | 2008-10-03 | 0000-00-00 | No | No | Current |
| 55111-476-79 | 55111047679 | 10 in 1 BLISTER PACK | Historical |