PredniSONE Tablets, USP, 20 mg
- Product NDC
- 72789-500
- 11-digit product format
- 727890500
- Labeler code
- 72789
- Product ID
- 72789-500_4e04898e-119a-d5a7-e063-6394a90acef8
- 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
- 20 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PredniSONE Tablets, USP, 20 mg
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREDNISONE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VB0R961HZT |
| Rxcui | 312615 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-500-21 | PredniSONE Tablets, USP, 20 mg | 21 in 1 BOTTLE, PLASTIC | TABLET | 21 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-500 | PREDNISONE TABLETS, USP, 20 MG (PREDNISONE) TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | Current NDC, 1 package rows | 20250507_3befbdc5-7d20-41b6-ad80-98e1c6b8caf5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-500-21 | 72789050021 | 21 TABLET in 1 BOTTLE, PLASTIC (72789-500-21) | 21 tablet | 2025-05-22 | No | No | Historical |