PredniSONE
- Product NDC
- 51655-763
- 11-digit product format
- 516550763
- Labeler code
- 51655
- Product ID
- 51655-763_4951ac49-5bba-db7c-e063-6394a90a1d2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA087801
- Marketing category
- ANDA
- Marketing start
- 2021-07-16
- Substance
- PREDNISONE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PredniSONE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREDNISONE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VB0R961HZT |
| Rxcui | 198146 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-763-52 | PredniSONE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-763 | PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 1 package rows | 20241228_da6fce58-0ef9-f3b1-e053-2995a90a1bec.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 |
|---|
| 51655-763-52 | 51655076352 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-763-52) | 30 tablet | 2021-07-16 | No | No | Historical |