PredniSONE
- Product NDC
- 0615-8391
- 11-digit product format
- 006158391
- Labeler code
- 0615
- Product ID
- 0615-8391_cf6fd1f9-5c11-40a4-96de-0172ad61d7e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA084122
- Marketing category
- ANDA
- Marketing start
- 2020-03-23
- Marketing end
- 2024-06-30
- Substance
- PREDNISONE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8391-05 | 00615839105 | 15 TABLET in 1 BLISTER PACK (0615-8391-05) | 15 tablet | 2021-03-03 | 0000-00-00 | No | No | Current |
| 0615-8391-30 | 00615839130 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8391-30) > 5 TABLET in 1 BLISTER PACK | 6 blister pack | 2021-03-11 | 0000-00-00 | No | No | Current |
| 0615-8391-39 | 00615839139 | 30 TABLET in 1 BLISTER PACK (0615-8391-39) | 30 tablet | 2021-03-03 | 0000-00-00 | No | No | Current |