Prednisolone
- Product NDC
- 67296-1656
- 11-digit product format
- 672961656
- Labeler code
- 67296
- Product ID
- 67296-1656_1f3e9f53-9ced-a048-e063-6294a90ae1a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisolone
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- RedPharm Drug, Inc.
- Application
- ANDA040401
- Marketing category
- ANDA
- Marketing start
- 2003-02-27
- 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 |
|---|---|
| PREDNISOLONE | 15 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 9PHQ9Y1OLM |
| Rxcui | 283077 |
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 |
|---|---|---|---|---|---|
| 67296-1656-6 | 2024-08-09 | C162847 | 48780-1 | 1030e365-5f01-111a-e063-dadaa90a10e2 | PREDNISOLONE ORAL SOLUTION 15 mg per 5 mL |
| 67296-1656-6 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5f01-111a-e063-dadaa90a10e2 | PREDNISOLONE ORAL SOLUTION 15 mg per 5 mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67296-1656-6 | Prednisolone | 60 mL in 1 BOTTLE | SOLUTION | 60 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67296-1656 | PREDNISOLONE SOLUTION [REDPHARM DRUG, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240810_b339a007-6a1e-6578-e053-2995a90a53d0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283077 | prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution | PSN | b339a007-6a1e-6578-e053-2995a90a53d0 | 3 |
| 283077 | prednisolone 3 MG/ML Oral Solution | SCD | b339a007-6a1e-6578-e053-2995a90a53d0 | 3 |
| 283077 | prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution | SY | b339a007-6a1e-6578-e053-2995a90a53d0 | 3 |
| 283077 | prednisolone 15 MG per 5 ML Oral Solution | SY | b339a007-6a1e-6578-e053-2995a90a53d0 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67296-1656-6 | 67296165606 | 60 mL in 1 BOTTLE (67296-1656-6) | 60 ml | 2003-02-27 | 0000-00-00 | No | No | Current |