PredniSONE
- Product NDC
- 50436-4324
- 11-digit product format
- 504364324
- Labeler code
- 50436
- Product ID
- 50436-4324_2ab26951-c3f2-44a5-903a-1ad2b9dded0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA080352
- Marketing category
- ANDA
- Marketing start
- 1972-04-21
- Marketing end
- 0000-00-00
- Substance
- PREDNISONE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50436-4324-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2320-f424-e053-dadaa90a57ce | PredniSONE Tablets USP, 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg, PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL |
| 50436-4324-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2320-f424-e053-dadaa90a57ce | PredniSONE Tablets USP, 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg, PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL |
| 50436-4324-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2320-f424-e053-dadaa90a57ce | PredniSONE Tablets USP, 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg, PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50436-4324-1 | PredniSONE | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 50436-4324-2 | PredniSONE | 15 in 1 BOTTLE | TABLET | 15 | | 4 |
| 50436-4324-3 | PredniSONE | 21 in 1 BOTTLE | TABLET | 21 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-4324 | PREDNISONE TABLET [UNIT DOSE SERVICES] | 4 | Legacy NDC, 3 package rows | 20140331_9269619e-4fa9-459e-aed8-35d9fde140a5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 50436-4324-1 | 50436432401 | 30 in 1 BOTTLE | Historical |
| 50436-4324-2 | 50436432402 | 15 in 1 BOTTLE | Historical |
| 50436-4324-3 | 50436432403 | 21 in 1 BOTTLE | Historical |