PredniSONE
- Product NDC
- 17856-3722
- 11-digit product format
- 178563722
- Labeler code
- 17856
- Product ID
- 17856-3722_35d2e5c3-3d05-e219-e063-6294a90acf21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corps
- Application
- ANDA088703
- Marketing category
- ANDA
- Marketing start
- 1986-12-13
- 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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 17856-3722-1 | 2025-04-18 | C162847 | 48780-1 | 9d75b9d0-fb74-f424-e053-dadaa90a57ce | PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL |
| 17856-3722-1 | 2025-04-18 | C162847 | 48780-1 | 9d75b9d0-fb74-f424-e053-dadaa90a57ce | PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL |
| 17856-3722-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-fb74-f424-e053-dadaa90a57ce | PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL |
| 17856-3722-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-fb74-f424-e053-dadaa90a57ce | 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 |
|---|
| 17856-3722-1 | PredniSONE | 5 mL in 1 CUP | SOLUTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-3722 | PREDNISONE SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250525_07be390e-ef1e-4bf9-a9da-4338b5f6cfa5.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 |
|---|
| 17856-3722-1 | 17856372201 | 5 mL in 1 CUP (17856-3722-1) | 5 ml | 2016-05-05 | No | No | Historical |