FDA.reportPublic FDA data

Prednisolone Sodium Phosphate

Product NDC
50090-0955
11-digit product format
500900955
Labeler code
50090
Product ID
50090-0955_10364c02-df36-43e2-9197-7a218a5fa019
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076895
Marketing category
ANDA
Marketing start
2004-10-04
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
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
50090-0955-02023-01-30C16284748780-1f386c64a-2bbd-0266-e053-dadaa90a7c1aPREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION, 15 mg/5 mL Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0955-0Prednisolone Sodium Phosphate237 mL in 1 BOTTLE, PLASTICSOLUTION2377

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0955-0ML - Milliliter50090-09558f665f53-f45f-4f4b-af16-cd850180840212018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0955PREDNISOLONE SODIUM PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20190126_dfbab230-113f-4da7-94f0-76111c681d32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNdfbab230-113f-4da7-94f0-76111c681d327
283077prednisolone 3 MG/ML Oral SolutionSCDdfbab230-113f-4da7-94f0-76111c681d327
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYdfbab230-113f-4da7-94f0-76111c681d327
283077prednisolone 15 MG per 5 ML Oral SolutionSYdfbab230-113f-4da7-94f0-76111c681d327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0955-050090095500237 mL in 1 BOTTLE, PLASTIC (50090-0955-0) 237 ml2014-11-280000-00-00NoNoCurrent