PREDNISOLONE
- Product NDC
- 42658-160
- 11-digit product format
- 426580160
- Labeler code
- 42658
- Product ID
- 42658-160_9f93400d-a8c0-435a-ad65-48717cc455cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREDNISOLONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hisun Pharmaceuticals USA, Inc.
- Application
- ANDA218083
- Marketing category
- ANDA
- Marketing start
- 2024-09-01
- 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 |
|---|
| 42658-160-05 | PREDNISOLONE | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42658-160 | PREDNISOLONE TABLET [HISUN PHARMACEUTICALS USA, INC.] | 1 | Current NDC, 1 package rows | 20240901_16d4e064-66d3-4497-8c7d-3aa355f91e1d.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 |
|---|
| 42658-160-05 | 42658016005 | 100 TABLET in 1 BOTTLE (42658-160-05) | 100 tablet | 2024-09-01 | No | No | Historical |