FDA.reportPublic FDA data

Prednisolone Sodium Phosphate

Product NDC
50090-1582
11-digit product format
500901582
Labeler code
50090
Product ID
50090-1582_9cdcdc91-0b2c-43eb-9891-a581be9bdb30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076913
Marketing category
ANDA
Marketing start
2005-04-25
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
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 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
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1582-02023-02-07C16284748780-1f386c64a-4004-0266-e053-dadaa90a7c1aPREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (15 mg Prednisolone Base per 5 mL)
50090-1582-02023-01-30C16284748780-1f386c64a-4004-0266-e053-dadaa90a7c1aPREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (15 mg Prednisolone Base per 5 mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1582-0Prednisolone Sodium Phosphate237 mL in 1 BOTTLESOLUTION23718

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1582-0ML - Milliliter50090-1582c93a7bfe-8cfa-45f7-8ef7-6ca1b69cea6912021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1582PREDNISOLONE SODIUM PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 1 package rows20250302_4c507319-8add-4952-8bea-ff77ab17088f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN4c507319-8add-4952-8bea-ff77ab17088f18
283077prednisolone 3 MG/ML Oral SolutionSCD4c507319-8add-4952-8bea-ff77ab17088f18
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY4c507319-8add-4952-8bea-ff77ab17088f18
283077prednisolone 15 MG per 5 ML Oral SolutionSY4c507319-8add-4952-8bea-ff77ab17088f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1582-050090158200237 mL in 1 BOTTLE (50090-1582-0) 237 ml2014-12-290000-00-00NoNoCurrent