PredniSONE
- Product NDC
- 51655-493
- 11-digit product format
- 516550493
- Labeler code
- 51655
- Product ID
- 51655-493_490f89bb-255b-5669-e063-6394a90a4a53
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA084122
- Marketing category
- ANDA
- Marketing start
- 2021-01-13
- Substance
- PREDNISONE
- Active strength
- 10 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 | 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 |
|---|
| 51655-493-49 | PredniSONE | 42 in 1 BOTTLE, PLASTIC | TABLET | 42 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-493 | PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 1 package rows | 20241225_dad4f191-8893-48e0-e053-2995a90ae864.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 |
|---|
| 51655-493-49 | 51655049349 | 42 TABLET in 1 BOTTLE, PLASTIC (51655-493-49) | 42 tablet | 2021-01-13 | No | No | Historical |