PredniSONE
- Product NDC
- 55289-330
- 11-digit product format
- 552890330
- Labeler code
- 55289
- Product ID
- 55289-330_419e633a-5422-21c2-e063-6394a90a9634
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA084283
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55289-330-05 | PredniSONE | 5 in 1 BOTTLE, PLASTIC | TABLET | 5 | | 25 |
| 55289-330-07 | PredniSONE | 7 in 1 BOTTLE, PLASTIC | TABLET | 7 | | 25 |
| 55289-330-10 | PredniSONE | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | | 25 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PREDNISONE | ACTIVE INGREDIENT | VB0R961HZT | PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| PREDNISONE | ACTIVE MOIETY | VB0R961HZT | PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-330 | PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.] | 24 | Current NDC, Legacy NDC, 3 package rows | 20240713_5b2f4fa9-817c-43c9-ac9a-750ab1d1f66f.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 |
|---|
| 55289-330-05 | 55289033005 | 5 TABLET in 1 BOTTLE, PLASTIC (55289-330-05) | 5 tablet | 2009-11-18 | 0000-00-00 | No | No | Current |
| 55289-330-07 | 55289033007 | 7 TABLET in 1 BOTTLE, PLASTIC (55289-330-07) | 7 tablet | 2009-11-18 | 0000-00-00 | No | No | Current |
| 55289-330-10 | 55289033010 | 10 TABLET in 1 BOTTLE, PLASTIC (55289-330-10) | 10 tablet | 2009-11-18 | 0000-00-00 | No | No | Current |