PredniSONE
- Product NDC
- 0054-3722
- 11-digit product format
- 000543722
- Labeler code
- 0054
- Product ID
- 0054-3722_523ad364-8d95-4679-9290-446d61f36eb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA088703
- Marketing category
- ANDA
- Marketing start
- 1984-11-08
- Substance
- PREDNISONE
- Active strength
- 5 mg/5mL
- 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/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VB0R961HZT |
| Rxcui | 198144, 198145, 198146, 198148, 205301, 312615, 312617, 315187 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0054-3722-50 | 2022-08-04 | C162847 | 48780-1 | e4f33bdf-a799-d8a0-e053-dadaa90a6e4e | PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate) |
| 0054-3722-63 | 2022-08-04 | C162847 | 48780-1 | e4f33bdf-a799-d8a0-e053-dadaa90a6e4e | PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate) |
| 0054-3722-50 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a799-d8a0-e053-dadaa90a6e4e | PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate) |
| 0054-3722-63 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a799-d8a0-e053-dadaa90a6e4e | PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate) |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-3722-50 | PredniSONE | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 24 |
| 0054-3722-63 | PredniSONE | 500 mL in 1 BOTTLE | SOLUTION | 500 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-3722 | PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.] | 23 | Current NDC, Legacy NDC, 2 package rows | 20240308_3115aef0-fd50-4ec8-a064-3effb695f3f2.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 |
|---|
| 0054-3722-50 | 00054372250 | 120 mL in 1 BOTTLE (0054-3722-50) | 120 ml | 1996-12-13 | 0000-00-00 | No | No | Current |
| 0054-3722-63 | 00054372263 | 500 mL in 1 BOTTLE (0054-3722-63) | 500 ml | 1984-11-08 | 0000-00-00 | No | No | Current |