PredniSONE
- Product NDC
- 51655-939
- 11-digit product format
- 516550939
- Labeler code
- 51655
- Product ID
- 51655-939_497450db-876a-701a-e063-6394a90a62ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA084283
- Marketing category
- ANDA
- Marketing start
- 2022-08-04
- Substance
- PREDNISONE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VB0R961HZT |
| Rxcui | 198148 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-939-07 | PredniSONE | 7 in 1 BOTTLE, PLASTIC | TABLET | 7 | | 4 |
| 51655-939-55 | PredniSONE | 5 in 1 BOTTLE, PLASTIC | TABLET | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-939 | PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 2 package rows | 20241228_f77f4a5a-b307-84ff-e053-6294a90aba5b.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 |
|---|
| 51655-939-07 | 51655093907 | 7 TABLET in 1 BOTTLE, PLASTIC (51655-939-07) | 7 tablet | 2022-09-27 | No | No | Historical |
| 51655-939-55 | 51655093955 | 5 TABLET in 1 BOTTLE, PLASTIC (51655-939-55) | 5 tablet | 2022-08-04 | No | No | Historical |