PredniSONE Tablets, USP, 5 mg
- Product NDC
- 72789-498
- 11-digit product format
- 727890498
- Labeler code
- 72789
- Product ID
- 72789-498_4e0460fe-06e7-7c55-e063-6294a90a8419
- 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
- 5 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, 5 mg
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREDNISONE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VB0R961HZT |
| Rxcui | 312617 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-498-30 | PredniSONE Tablets, USP, 5 mg | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-498 | PREDNISONE TABLETS, USP, 5 MG (PREDNISONE) TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | Current NDC, 1 package rows | 20250519_251e9fe7-b1f5-4b5b-b5fa-8c8be43e284e.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 |
|---|
| 72789-498-30 | 72789049830 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-498-30) | 30 tablet | 2025-05-22 | No | No | Current |