Prednisolone Sodium Phosphate
- Product NDC
- 65162-667
- 11-digit product format
- 651620667
- Labeler code
- 65162
- Product ID
- 65162-667_7130442d-321c-496f-a71a-e4eea25509d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisolone Sodium Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA078345
- Marketing category
- ANDA
- Marketing start
- 2009-12-01
- Marketing end
- 0000-00-00
- Substance
- PREDNISOLONE SODIUM PHOSPHATE
- Active strength
- 15 mg/5mL
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|---|---|---|---|---|
| 65162-667-76 | 2026-01-14 | C162847 | 48780-1 | f386c649-d435-0266-e053-dadaa90a7c1a | 6e860843-b491-4c6e-a0ff-4f24f7d4e257 |
| 65162-667-88 | 2026-01-14 | C162847 | 48780-1 | f386c649-d435-0266-e053-dadaa90a7c1a | 6e860843-b491-4c6e-a0ff-4f24f7d4e257 |
| 65162-667-90 | 2026-01-14 | C162847 | 48780-1 | f386c649-d435-0266-e053-dadaa90a7c1a | 6e860843-b491-4c6e-a0ff-4f24f7d4e257 |
| 65162-667-76 | 2023-01-30 | C162847 | 48780-1 | f386c649-d435-0266-e053-dadaa90a7c1a | 6e860843-b491-4c6e-a0ff-4f24f7d4e257 |
| 65162-667-88 | 2023-01-30 | C162847 | 48780-1 | f386c649-d435-0266-e053-dadaa90a7c1a | 6e860843-b491-4c6e-a0ff-4f24f7d4e257 |
| 65162-667-90 | 2023-01-30 | C162847 | 48780-1 | f386c649-d435-0266-e053-dadaa90a7c1a | 6e860843-b491-4c6e-a0ff-4f24f7d4e257 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65162-667-88 | ML - Milliliter | 65162-667 | 1cc9535f-6403-4132-aa9b-741c8c037cb1 | 1 | 2012-07-24 |
| 65162-667-90 | ML - Milliliter | 65162-667 | 5d515d22-6ffc-4cc3-9e31-313d842a902a | 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 | de240524-7865-46a2-aa11-d06356ba9339 | 1 |
| 283077 | prednisolone 3 MG/ML Oral Solution | SCD | de240524-7865-46a2-aa11-d06356ba9339 | 1 |
| 283077 | prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution | SY | de240524-7865-46a2-aa11-d06356ba9339 | 1 |
| 283077 | prednisolone 15 MG per 5 ML Oral Solution | SY | de240524-7865-46a2-aa11-d06356ba9339 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65162-667-76 | 65162066776 | 89 mL in 1 BOTTLE (65162-667-76) | 89 ml | 2009-12-01 | 0000-00-00 | No | No | Current |
| 65162-667-88 | 65162066788 | 237 mL in 1 BOTTLE (65162-667-88) | 237 ml | 2009-12-01 | 0000-00-00 | No | No | Current |
| 65162-667-90 | 65162066790 | 473 mL in 1 BOTTLE (65162-667-90) | 473 ml | 2009-12-01 | 0000-00-00 | No | No | Current |