Prednisolone
- Product NDC
- 0121-0885
- 11-digit product format
- 001210885
- Labeler code
- 0121
- Product ID
- 0121-0885_1166b85b-73c5-4a8f-bc41-f99b406d0ff5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisolone
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA040571
- Marketing category
- ANDA
- Marketing start
- 2023-09-12
- Substance
- PREDNISOLONE
- Active strength
- 15 mg/5mL
- 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 | 15 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9PHQ9Y1OLM |
| Rxcui | 283077 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-0885-08 | Prednisolone | 240 mL in 1 BOTTLE | SOLUTION | 240 | | 2 |
| 0121-0885-16 | Prednisolone | 480 mL in 1 BOTTLE | SOLUTION | 480 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0885 | PREDNISOLONE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 2 | Current NDC, 2 package rows | 20240820_cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3.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 |
|---|
| 0121-0885-08 | 00121088508 | 240 mL in 1 BOTTLE (0121-0885-08) | 240 ml | 2023-09-12 | No | No | Historical |
| 0121-0885-16 | 00121088516 | 480 mL in 1 BOTTLE (0121-0885-16) | 480 ml | 2023-09-12 | No | No | Historical |