PredniSONE
- Product NDC
- 68071-3581
- 11-digit product format
- 680713581
- Labeler code
- 68071
- Product ID
- 68071-3581_1289ccc0-8def-ceab-e063-6294a90ac106
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA080352
- Marketing category
- ANDA
- Marketing start
- 2020-03-23
- Substance
- PREDNISONE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| VB0R961HZT | PREDNISONE | 53-03-2 | PREDNISONE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3581-1 | 68071358101 | 100 TABLET in 1 BOTTLE (68071-3581-1) | 100 tablet | 2024-02-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| PredniSONE Tablets, USP | NuCare Pharmaceuticals,Inc. | 2024-02-29 | HUMAN PRESCRIPTION DRUG LABEL | 1 |