Prednisolone
- Product NDC
- 21695-365
- 11-digit product format
- 216950365
- Labeler code
- 21695
- Product ID
- 21695-365_8bea1481-939d-4bea-a366-0ea435d81288
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisolone
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 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 |
|---|---|---|---|---|---|
| 21695-365-08 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49d4-48b1-e053-8cdaa90a720a | PREDNISOLONE |
| 21695-365-16 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49d4-48b1-e053-8cdaa90a720a | PREDNISOLONE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-365-08 | Prednisolone | 240 mL in 1 BOTTLE | SOLUTION | 240 | 1 | |
| 21695-365-16 | Prednisolone | 480 mL in 1 BOTTLE | SOLUTION | 480 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-365-08 | ML - Milliliter | 21695-365 | 3440e1a2-44be-46cd-8fc9-40d12c5d29fc | 1 | 2012-07-24 |
| 21695-365-16 | ML - Milliliter | 21695-365 | d5dc5e21-f812-4ed7-bed4-e9c1d409b891 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 | 8bea1481-939d-4bea-a366-0ea435d81288 | 1 |
| 283077 | prednisolone 3 MG/ML Oral Solution | SCD | 8bea1481-939d-4bea-a366-0ea435d81288 | 1 |
| 283077 | prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution | SY | 8bea1481-939d-4bea-a366-0ea435d81288 | 1 |
| 283077 | prednisolone 15 MG per 5 ML Oral Solution | SY | 8bea1481-939d-4bea-a366-0ea435d81288 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-365-08 | 21695036508 | 240 mL in 1 BOTTLE | 240 ml | Historical |
| 21695-365-16 | 21695036516 | 480 mL in 1 BOTTLE | 480 ml | Historical |