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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Primidone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRIMIDONE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 13AFD7670Q |
| Rxcui | 96304, 198150 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-476 | PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LIMITED] | 3 | Current NDC, Legacy NDC, 6 package rows | 20171206_a4f917f4-2aa2-c3ed-071e-232fa0f125e8.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 |
|---|
| 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 |