Prednisolone Sodium Phosphate

Product NDC
81646-118
11-digit product format
816460118
Labeler code
81646
Product ID
81646-118_871e80dd-3a5d-4e30-bd2e-90c25c052b32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
PINNACLE PHARMA LLC
Application
ANDA078988
Marketing category
ANDA
Marketing start
2017-01-31
Marketing end
0000-00-00
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
20 mg/5mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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
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
81646-118-052023-01-30C16284748780-1f386c649-ada6-0266-e053-dadaa90a7c1aPREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (20 mg prednisolone base per 5 mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81646-118-05Prednisolone Sodium Phosphate5 mL in 1 CUP, UNIT-DOSESOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81646-118PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PINNACLE PHARMA LLC]1Legacy NDC, 1 package rows20210710_1d247de0-f2e2-43a6-8698-1b2ea6b44260.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702306prednisoLONE sodium phosphate 20 MG in 5 mL Oral SolutionPSN1d247de0-f2e2-43a6-8698-1b2ea6b442601
702306prednisolone 4 MG/ML Oral SolutionSCD1d247de0-f2e2-43a6-8698-1b2ea6b442601
702306prednisolone 20 MG (as prednisolone sodium phosphate 26.9 MG) per 5 ML Oral SolutionSY1d247de0-f2e2-43a6-8698-1b2ea6b442601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81646-118-05816460118055 mL in 1 CUP, UNIT-DOSE (81646-118-05) 5 ml2017-01-310000-00-00NoNoCurrent