Primidone
- Product NDC
- 71610-079
- 11-digit product format
- 716100079
- Labeler code
- 71610
- Product ID
- 71610-079_2d04438d-30db-4621-aa15-03b25aa283ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA040586
- Marketing category
- ANDA
- Marketing start
- 2018-03-28
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-079 | PRIMIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC | 20180703_3e081b24-20f5-4ffd-b493-771fd4ac2c96.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-079-60 | 71610007960 | 90 TABLET in 1 BOTTLE, PLASTIC (71610-079-60) | 90 tablet | 2018-05-31 | 0000-00-00 | No | No | Current |
| 71610-079-80 | 71610007980 | 180 TABLET in 1 BOTTLE, PLASTIC (71610-079-80) | 180 tablet | 2018-05-31 | 0000-00-00 | No | No | Current |
| 71610-079-94 | 71610007994 | 360 TABLET in 1 BOTTLE, PLASTIC (71610-079-94) | 360 tablet | 2018-05-31 | 0000-00-00 | No | No | Current |