Prednisolone
- Product NDC
- 53217-193
- 11-digit product format
- 532170193
- Labeler code
- 53217
- Product ID
- 53217-193_7d392866-ceb6-4c51-a581-27e0fb27c17e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisolone
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA040401
- Marketing category
- ANDA
- Marketing start
- 2003-02-27
- Marketing end
- 0000-00-00
- Substance
- PREDNISOLONE
- Active strength
- 15 mg/5mL
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b3fecff3-fb51-4f66-b443-a130905bb500 | Product name | 1 | 20250804 |
| 3a7a0034-a88d-88c3-f43e-ea34c6a216de | Product name | 2 | 20250311 |
| 9dbc4744-f7be-4393-b71a-e1bfd8b97659 | Product name | 2 | 20250218 |
| 9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5 | Product name | 2 | 20240102 |
| a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a | Product name | 1 | 20170309 |
| af7d3306-1338-423f-839e-419aad9e8a86 | Product name | 1 | 20170309 |
| 18d57d04-4a34-a130-5dd5-b7fc47f3b567 | Product name | 1 | 20140508 |
| 379bc253-901a-e6e1-92b7-0fc574249e07 | Product name | 1 | 20140508 |
| 48b05f5d-d2fc-45ab-76e8-3cb5bd44890d | Product name | 1 | 20140508 |
| 73adedd8-aba8-27d9-78d9-2e3c4a3cf954 | Product name | 1 | 20140508 |
| 9ae74339-0a3d-82e9-5dd1-88bd2607bd6b | Product name | 1 | 20140508 |
| 9f10552a-9a7b-8e6c-3223-dc44310af6cf | Product name | 1 | 20140508 |
| e44e38a9-2d9e-b0e2-cce9-490554639f3d | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53217-193-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d1f3-f424-e053-dadaa90a57ce | PREDNISOLONE ORAL SOLUTION USP 15 mg per 5 mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53217-193-01 | Prednisolone | 240 mL in 1 BOTTLE | SOLUTION | 240 | 1 | |
| 53217-193-01 | Prednisolone | 1 in 1 CARTON | SOLUTION | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53217-193-01 | ML - Milliliter | 53217-193 | 6e134044-9b8b-49e7-a31e-c6462e0fe045 | 1 | 2017-03-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283077 | prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution | PSN | fd5a9d06-81ca-4f26-86de-4b1bda6e86be | 1 |
| 283077 | prednisolone 3 MG/ML Oral Solution | SCD | fd5a9d06-81ca-4f26-86de-4b1bda6e86be | 1 |
| 283077 | prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution | SY | fd5a9d06-81ca-4f26-86de-4b1bda6e86be | 1 |
| 283077 | prednisolone 15 MG per 5 ML Oral Solution | SY | fd5a9d06-81ca-4f26-86de-4b1bda6e86be | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 53217-193-01 | 53217019301 | 240 mL in 1 BOTTLE | 240 ml | Historical |