PREDNISOLONE
- Product NDC
- 60722-5011
- 11-digit product format
- 607225011
- Labeler code
- 60722
- Product ID
- 60722-5011_da9dfcf4-1631-4923-9536-72c27fc0b307
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREDNISOLONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zhejiang Xianju Pharmaceutical Co., Ltd.
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PREDNISOLONE
- Listing expiration
- 2027-12-31
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 |
|---|
| 60722-5011-0 | PREDNISOLONE | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 60722-5011-1 | PREDNISOLONE | 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 |
|---|
| 60722-5011 | PREDNISOLONE TABLET [ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD.] | 1 | Current NDC, 2 package rows | 20240901_52e6e21d-94b8-41a0-8d13-371c0e66bcee.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 |
|---|
| 60722-5011-0 | 60722501100 | 100 TABLET in 1 BOTTLE (60722-5011-0) | 100 tablet | 2024-09-01 | No | No | Historical |
| 60722-5011-1 | 60722501101 | 1000 TABLET in 1 BOTTLE (60722-5011-1) | 1000 tablet | 2024-09-01 | No | No | Historical |