PredniSONE
- Product NDC
- 70518-4271
- 11-digit product format
- 705184271
- Labeler code
- 70518
- Product ID
- 70518-4271_4018f32d-5c0d-392b-e063-6394a90a83eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA080352
- Marketing category
- ANDA
- Marketing start
- 2025-01-30
- 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 |
|---|
| 70518-4271-0 | PredniSONE | 100 in 1 BOX | TABLET | 100 | | 3 |
| 70518-4271-1 | PredniSONE | 1 in 1 POUCH | TABLET | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4271 | PREDNISONE TABLET [REMEDYREPACK INC.] | 1 | Current NDC, 2 package rows | 20250206_7db793b4-5768-4e9a-a47b-1ebbfed74001.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 |
|---|
| 70518-4271-0 | 70518427100 | 100 POUCH in 1 BOX (70518-4271-0) / 1 TABLET in 1 POUCH (70518-4271-1) | 100 pouch | 2025-01-30 | No | No | Current |
| 70518-4271-1 | 70518427101 | 1 in 1 POUCH | | | | | Historical |