FDA.reportPublic FDA data

Prednisolone Sodium Phosphate

Product NDC
70518-4524
11-digit product format
705184524
Labeler code
70518
Product ID
70518-4524_4a78234e-7fc3-5901-e063-6294a90a71c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076913
Marketing category
ANDA
Marketing start
2025-11-28
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
15 mg/5mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prednisolone Sodium Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISOLONE SODIUM PHOSPHATE15 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIV021NXA9J
Rxcui283077

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
70518-4524-0Prednisolone Sodium Phosphate2 in 1 BOXSOLUTION23
70518-4524-1Prednisolone Sodium Phosphate25 mL in 1 CUPSOLUTION253
70518-4524-2Prednisolone Sodium Phosphate5 in 1 BOXSOLUTION53
70518-4524-3Prednisolone Sodium Phosphate10 mL in 1 CUPSOLUTION103
70518-4524-4Prednisolone Sodium Phosphate10 in 1 BOXSOLUTION103
70518-4524-5Prednisolone Sodium Phosphate5 mL in 1 CUPSOLUTION53

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNf87ce1ba-335e-463d-87d5-9af0206f8f613
283077prednisolone 3 MG/ML Oral SolutionSCDf87ce1ba-335e-463d-87d5-9af0206f8f613
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYf87ce1ba-335e-463d-87d5-9af0206f8f613
283077prednisolone 15 MG per 5 ML Oral SolutionSYf87ce1ba-335e-463d-87d5-9af0206f8f613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4524-0705184524002 CUP in 1 BOX (70518-4524-0) / 25 mL in 1 CUP (70518-4524-1) 2 cup2025-11-28NoNoCurrent
70518-4524-17051845240125 mL in 1 CUP25 mlHistorical
70518-4524-2705184524025 CUP in 1 BOX (70518-4524-2) / 10 mL in 1 CUP (70518-4524-3) 5 cup2025-12-10NoNoCurrent
70518-4524-37051845240310 mL in 1 CUP10 mlHistorical
70518-4524-47051845240410 CUP in 1 BOX (70518-4524-4) / 5 mL in 1 CUP (70518-4524-5) 10 cup2026-02-09NoNoCurrent
70518-4524-5705184524055 mL in 1 CUP5 mlHistorical