PredniSONE Tablets, USP, 10 mg
- Product NDC
- 72789-475
- 11-digit product format
- 727890475
- Labeler code
- 72789
- Product ID
- 72789-475_4ddfc5f0-5f52-0667-e063-6294a90a0a83
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PredniSONE Tablets, USP, 10 mg
- Listing expiration
- 2027-12-31
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 |
|---|
| 72789-475-01 | PredniSONE Tablets, USP, 10 mg | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 10 |
| 72789-475-04 | PredniSONE Tablets, USP, 10 mg | 4 in 1 BOTTLE, PLASTIC | TABLET | 4 | | 10 |
| 72789-475-12 | PredniSONE Tablets, USP, 10 mg | 12 in 1 BOTTLE, PLASTIC | TABLET | 12 | | 10 |
| 72789-475-21 | PredniSONE Tablets, USP, 10 mg | 21 in 1 BOTTLE, PLASTIC | TABLET | 21 | | 10 |
| 72789-475-30 | PredniSONE Tablets, USP, 10 mg | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 10 |
| 72789-475-40 | PredniSONE Tablets, USP, 10 mg | 40 in 1 BOTTLE, PLASTIC | TABLET | 40 | | 10 |
| 72789-475-50 | PredniSONE Tablets, USP, 10 mg | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | | 10 |
| 72789-475-95 | PredniSONE Tablets, USP, 10 mg | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-475 | PREDNISONE TABLETS, USP, 10 MG (PREDNISONE) TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | Current NDC, 8 package rows | 20250214_14d50f54-410b-45b2-a639-31498ceaf854.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 |
|---|
| 72789-475-01 | 72789047501 | 100 TABLET in 1 BOTTLE, PLASTIC (72789-475-01) | 100 tablet | 2025-05-22 | No | No | Current |
| 72789-475-04 | 72789047504 | 4 TABLET in 1 BOTTLE, PLASTIC (72789-475-04) | 4 tablet | 2025-12-24 | No | No | Current |
| 72789-475-12 | 72789047512 | 12 TABLET in 1 BOTTLE, PLASTIC (72789-475-12) | 12 tablet | 2025-07-23 | No | No | Current |
| 72789-475-21 | 72789047521 | 21 TABLET in 1 BOTTLE, PLASTIC (72789-475-21) | 21 tablet | 2025-06-24 | No | No | Current |
| 72789-475-30 | 72789047530 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-475-30) | 30 tablet | 2025-12-16 | No | No | Current |
| 72789-475-40 | 72789047540 | 40 TABLET in 1 BOTTLE, PLASTIC (72789-475-40) | 40 tablet | 2025-09-03 | No | No | Current |
| 72789-475-50 | 72789047550 | 50 TABLET in 1 BOTTLE, PLASTIC (72789-475-50) | 50 tablet | 2025-06-12 | No | No | Current |
| 72789-475-95 | 72789047595 | 1000 TABLET in 1 BOTTLE, PLASTIC (72789-475-95) | 1000 tablet | 2025-05-22 | No | No | Current |