PREDNISONE
- Product NDC
- 59651-486
- 11-digit product format
- 596510486
- Labeler code
- 59651
- Product ID
- 59651-486_d957f055-4838-49e6-ae32-604fb3056bc4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREDNISONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA215672
- Marketing category
- ANDA
- Marketing start
- 2022-03-28
- Substance
- PREDNISONE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VB0R961HZT |
| Rxcui | 198145, 198146, 198148, 312615, 312617 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-486-01 | PREDNISONE | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 59651-486-78 | PREDNISONE | 10 in 1 CARTON | TABLET | 10 | | 2 |
| 59651-486-78 | PREDNISONE | 10 in 1 BLISTER PACK | TABLET | 10 | | 2 |
| 59651-486-99 | PREDNISONE | 1000 in 1 BOTTLE | TABLET | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-486 | PREDNISONE TABLET [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, Legacy NDC, 4 package rows | 20240227_b1ac4c92-e1fd-4015-b172-0932790ae019.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 |
|---|
| 59651-486-01 | 59651048601 | 100 TABLET in 1 BOTTLE (59651-486-01) | 100 tablet | 2022-03-28 | 0000-00-00 | No | No | Current |
| 59651-486-78 | 59651048678 | 10 BLISTER PACK in 1 CARTON (59651-486-78) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2022-03-28 | 0000-00-00 | No | No | Current |
| 59651-486-99 | 59651048699 | 1000 TABLET in 1 BOTTLE (59651-486-99) | 1000 tablet | 2022-03-28 | 0000-00-00 | No | No | Current |