PredniSONE
- Product NDC
- 0054-9828
- 11-digit product format
- 000549828
- Labeler code
- 0054
- Product ID
- 0054-9828_249c4c6d-a058-489a-8f84-928c14bfd3f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA080352
- Marketing category
- ANDA
- Marketing start
- 2020-03-23
- 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 | 198145, 312615, 312617 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-9828-25 | PredniSONE | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 0054-9828-31 | PredniSONE | 1000 in 1 BOTTLE | TABLET | 1000 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-9828 | PREDNISONE TABLET [HIKMA PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250423_263ed4fa-3c29-4abb-9cb1-bc016bd34a05.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 |
|---|
| 0054-9828-25 | 00054982825 | 100 TABLET in 1 BOTTLE (0054-9828-25) | 100 tablet | 2020-03-23 | 0000-00-00 | No | No | Current |
| 0054-9828-31 | 00054982831 | 1000 TABLET in 1 BOTTLE (0054-9828-31) | 1000 tablet | 2020-03-23 | 0000-00-00 | No | No | Current |