PredniSONE
- Product NDC
- 70518-4191
- 11-digit product format
- 705184191
- Labeler code
- 70518
- Product ID
- 70518-4191_40948345-bcd5-cf1c-e063-6294a90a1725
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA084122
- Marketing category
- ANDA
- Marketing start
- 2024-09-30
- Substance
- PREDNISONE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VB0R961HZT |
| Rxcui | 198145 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4191-0 | PredniSONE | 14 in 1 BOTTLE, PLASTIC | TABLET | 14 | | 6 |
| 70518-4191-1 | PredniSONE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 6 |
| 70518-4191-2 | PredniSONE | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 6 |
| 70518-4191-3 | PredniSONE | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | | 6 |
| 70518-4191-4 | PredniSONE | 18 in 1 BOTTLE, PLASTIC | TABLET | 18 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4191 | PREDNISONE TABLET [REMEDYREPACK INC.] | 4 | Current NDC, 5 package rows | 20250418_94715919-70bd-46c9-95fc-e151adf39cf9.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 |
|---|
| 70518-4191-0 | 70518419100 | 14 in 1 BOTTLE, PLASTIC | | | | | Historical |
| 70518-4191-1 | 70518419101 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-4191-1) | 30 tablet | 2024-09-30 | No | No | Current |
| 70518-4191-2 | 70518419102 | 20 in 1 BOTTLE, PLASTIC | | | | | Historical |
| 70518-4191-3 | 70518419103 | 10 TABLET in 1 BOTTLE, PLASTIC (70518-4191-3) | 10 tablet | 2024-11-06 | No | No | Current |
| 70518-4191-4 | 70518419104 | 18 TABLET in 1 BOTTLE, PLASTIC (70518-4191-4) | 18 tablet | 2025-04-14 | No | No | Current |