PREDNISOLONE
- Product NDC
- 59651-491
- 11-digit product format
- 596510491
- Labeler code
- 59651
- Product ID
- 59651-491_c535b93f-b31f-411f-848c-b5e6782f321f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREDNISOLONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA215673
- Marketing category
- ANDA
- Marketing start
- 2023-03-17
- Substance
- PREDNISOLONE
- 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
- PREDNISOLONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREDNISOLONE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9PHQ9Y1OLM |
| Rxcui | 198142 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-491-01 | PREDNISOLONE | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 59651-491-50 | PREDNISOLONE | 50 in 1 BOTTLE | TABLET | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-491 | PREDNISOLONE TABLET [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 2 package rows | 20240301_070f1937-50a5-457f-bef5-4e597014e26d.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 |
|---|
| 59651-491-01 | 59651049101 | 100 TABLET in 1 BOTTLE (59651-491-01) | 100 tablet | 2023-03-17 | No | No | Current |
| 59651-491-50 | 59651049150 | 50 TABLET in 1 BOTTLE (59651-491-50) | 50 tablet | 2023-03-17 | No | No | Current |