PredniSONE Tablets, USP, 10 mg
- Product NDC
- 72789-513
- 11-digit product format
- 727890513
- Labeler code
- 72789
- Product ID
- 72789-513_3908276b-0535-d646-e063-6394a90ad695
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA212629
- Marketing category
- ANDA
- Marketing start
- 2025-05-22
- Substance
- PREDNISONE
- Active strength
- 10 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PredniSONE Tablets, USP, 10 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREDNISONE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VB0R961HZT |
| Rxcui | 198145 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-513-10 | PredniSONE Tablets, USP, 10 mg | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | | 5 |
| 72789-513-20 | PredniSONE Tablets, USP, 10 mg | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 5 |
| 72789-513-30 | PredniSONE Tablets, USP, 10 mg | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-513-10 | 72789051310 | 10 TABLET in 1 BOTTLE, PLASTIC (72789-513-10) | 10 tablet | 2025-06-17 | No | No | Current |
| 72789-513-20 | 72789051320 | 20 TABLET in 1 BOTTLE, PLASTIC (72789-513-20) | 20 tablet | 2025-07-03 | No | No | Current |
| 72789-513-30 | 72789051330 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-513-30) | 30 tablet | 2025-06-20 | No | No | Current |