PredniSONE
- Product NDC
- 0615-0536
- 11-digit product format
- 006150536
- Labeler code
- 0615
- Product ID
- 0615-0536_864eb7ba-7f13-4a36-bdad-163d656d115f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA080352
- Marketing category
- ANDA
- Marketing start
- 1972-04-21
- Marketing end
- 2023-03-31
- Substance
- PREDNISONE
- Active strength
- 5 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 |
|---|
| 0615-0536-05 | 00615053605 | 15 TABLET in 1 BLISTER PACK (0615-0536-05) | 15 tablet | 2018-10-24 | 0000-00-00 | No | No | Current |
| 0615-0536-30 | 00615053630 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-0536-30) > 5 TABLET in 1 BLISTER PACK | 6 blister pack | 2014-11-04 | 0000-00-00 | No | No | Current |
| 0615-0536-39 | 00615053639 | 30 TABLET in 1 BLISTER PACK (0615-0536-39) | 30 tablet | 2013-01-09 | 0000-00-00 | No | No | Current |