PredniSONE
- Product NDC
- 43063-968
- 11-digit product format
- 430630968
- Labeler code
- 43063
- Product ID
- 43063-968_3a21c358-f6b3-8e42-e063-6294a90a14cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA080352
- Marketing category
- ANDA
- Marketing start
- 1972-04-21
- Substance
- PREDNISONE
- Active strength
- 5 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
- Listing expiration
- 2026-12-31
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 |
|---|
| 43063-968-21 | PredniSONE | 21 in 1 BOTTLE, PLASTIC | TABLET | 21 | | 26 |
| 43063-968-30 | PredniSONE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 26 |
| 43063-968-55 | PredniSONE | 55 in 1 BOTTLE, PLASTIC | TABLET | 55 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-968 | PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.] | 25 | Current NDC, Legacy NDC, 3 package rows | 20240927_f4500eb6-d24a-4247-83f4-99e73346e328.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-968-21 | 43063096821 | 21 TABLET in 1 BOTTLE, PLASTIC (43063-968-21) | 21 tablet | 2019-04-09 | 0000-00-00 | No | No | Current |
| 43063-968-30 | 43063096830 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-968-30) | 30 tablet | 2019-04-11 | 0000-00-00 | No | No | Current |
| 43063-968-55 | 43063096855 | 55 TABLET in 1 BOTTLE, PLASTIC (43063-968-55) | 55 tablet | 2019-04-16 | 0000-00-00 | No | No | Current |