PredniSONE
- Product NDC
- 42708-045
- 11-digit product format
- 427080045
- Labeler code
- 42708
- Product ID
- 42708-045_45b3e0e2-7ec6-7419-e063-6394a90a2f2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- QPharma, Inc.
- Application
- ANDA084122
- Marketing category
- ANDA
- Marketing start
- 2003-02-13
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42708-045-21 | PredniSONE | 21 in 1 BOTTLE, PLASTIC | TABLET | 21 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42708-045 | PREDNISONE TABLET [QPHARMA, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240517_318fdf0d-c03a-4b48-a380-b7bb630363fb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42708-045-21 | 42708004521 | 21 TABLET in 1 BOTTLE, PLASTIC (42708-045-21) | 21 tablet | 2018-03-17 | 0000-00-00 | Yes | No | Current |