PredniSONE Tablets, USP, 5 mg
- Product NDC
- 72789-474
- 11-digit product format
- 727890474
- Labeler code
- 72789
- Product ID
- 72789-474_4ddfaff7-3273-e76e-e063-6294a90a01c9
- 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 |
|---|
| 72789-474-01 | PredniSONE Tablets, USP, 5 mg | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 8 |
| 72789-474-04 | PredniSONE Tablets, USP, 5 mg | 4 in 1 BOTTLE, PLASTIC | TABLET | 4 | | 8 |
| 72789-474-21 | PredniSONE Tablets, USP, 5 mg | 21 in 1 BOTTLE, PLASTIC | TABLET | 21 | | 8 |
| 72789-474-95 | PredniSONE Tablets, USP, 5 mg | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-474 | PREDNISONE TABLETS, USP, 5 MG (PREDNISONE) TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | Current NDC, 4 package rows | 20250214_d6df3295-3118-49af-be05-b1fab0d4adaa.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 |
|---|
| 72789-474-01 | 72789047401 | 100 TABLET in 1 BOTTLE, PLASTIC (72789-474-01) | 100 tablet | 2025-05-22 | No | No | Historical |
| 72789-474-04 | 72789047404 | 4 TABLET in 1 BOTTLE, PLASTIC (72789-474-04) | 4 tablet | 2025-12-24 | No | No | Historical |
| 72789-474-21 | 72789047421 | 21 TABLET in 1 BOTTLE, PLASTIC (72789-474-21) | 21 tablet | 2025-09-03 | No | No | Historical |
| 72789-474-95 | 72789047495 | 1000 TABLET in 1 BOTTLE, PLASTIC (72789-474-95) | 1000 tablet | 2025-05-22 | No | No | Historical |