PREDNISONE
- Product NDC
- 59651-484
- 11-digit product format
- 596510484
- Labeler code
- 59651
- Product ID
- 59651-484_6f9a9020-efd5-4f7d-90c7-11af33e93793
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREDNISONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA215671
- Marketing category
- ANDA
- Marketing start
- 2021-11-16
- Substance
- PREDNISONE
- Active strength
- 1 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VB0R961HZT |
| Rxcui | 198144 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-484-01 | PREDNISONE | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 59651-484-78 | PREDNISONE | 10 in 1 BLISTER PACK | TABLET | 10 | | 2 |
| 59651-484-78 | PREDNISONE | 10 in 1 CARTON | TABLET | 10 | | 2 |
| 59651-484-99 | 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 |
|---|
| 59651-484 | PREDNISONE TABLET [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, Legacy NDC, 4 package rows | 20240229_7b33767f-a520-4470-8f3f-4e86b38d615a.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 |
|---|
| 59651-484-01 | 59651048401 | 100 TABLET in 1 BOTTLE (59651-484-01) | 100 tablet | 2021-11-16 | 0000-00-00 | No | No | Current |
| 59651-484-78 | 59651048478 | 10 BLISTER PACK in 1 CARTON (59651-484-78) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2021-11-16 | 0000-00-00 | No | No | Current |
| 59651-484-99 | 59651048499 | 1000 TABLET in 1 BOTTLE (59651-484-99) | 1000 tablet | 2021-11-16 | 0000-00-00 | No | No | Current |