FDA.reportPublic FDA data

Prednisolone Sodium Phosphate

Product NDC
42799-816
11-digit product format
427990816
Labeler code
42799
Product ID
42799-816_462f70d9-438c-e6b2-e063-6394a90a1bbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA203559
Marketing category
ANDA
Marketing start
2023-05-01
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
25 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 Sodium Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISOLONE SODIUM PHOSPHATE25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIV021NXA9J
Rxcui249066, 283077, 702306, 794979

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
9f10552a-9a7b-8e6c-3223-dc44310af6cfProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42799-816-01Prednisolone Sodium Phosphate237 mL in 1 BOTTLE, PLASTICSOLUTION23714

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-816-01ML - Milliliter42799-81645b75730-5c41-4c81-9b31-87d22932963a12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-816PREDNISOLONE SODIUM PHOSPHATE SOLUTION [EDENBRIDGE PHARMACEUTICALS LLC.]12Current NDC, 1 package rows20250129_1793e218-7b49-497d-879f-1020de6e6d68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
794979prednisoLONE sodium phosphate 10 MG in 5 mL Oral SolutionPSN1793e218-7b49-497d-879f-1020de6e6d6814
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN1793e218-7b49-497d-879f-1020de6e6d6814
702306prednisoLONE sodium phosphate 20 MG in 5 mL Oral SolutionPSN1793e218-7b49-497d-879f-1020de6e6d6814
249066prednisoLONE sodium phosphate 25 MG in 5 mL Oral SolutionPSN1793e218-7b49-497d-879f-1020de6e6d6814
794979prednisolone 2 MG/ML Oral SolutionSCD1793e218-7b49-497d-879f-1020de6e6d6814
283077prednisolone 3 MG/ML Oral SolutionSCD1793e218-7b49-497d-879f-1020de6e6d6814
702306prednisolone 4 MG/ML Oral SolutionSCD1793e218-7b49-497d-879f-1020de6e6d6814
249066prednisolone 5 MG/ML Oral SolutionSCD1793e218-7b49-497d-879f-1020de6e6d6814
794979prednisolone 10 MG per 5 ML Oral SolutionSY1793e218-7b49-497d-879f-1020de6e6d6814
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY1793e218-7b49-497d-879f-1020de6e6d6814
283077prednisolone 15 MG per 5 ML Oral SolutionSY1793e218-7b49-497d-879f-1020de6e6d6814
702306prednisolone 20 MG (as prednisolone sodium phosphate 26.9 MG) per 5 ML Oral SolutionSY1793e218-7b49-497d-879f-1020de6e6d6814
249066prednisolone 25 MG (prednisolone sodium phosphate 33.6 MG) per 5 ML Oral SolutionSY1793e218-7b49-497d-879f-1020de6e6d6814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42799-816-0142799081601237 mL in 1 BOTTLE, PLASTIC (42799-816-01) 237 ml2023-05-01NoNoHistorical