FDA.reportPublic FDA data

Prednisolone Sodium Phosphate Oral Solution

Product NDC
44523-182
11-digit product format
445230182
Labeler code
44523
Product ID
44523-182_450e8d3f-b6f6-5251-e063-6394a90aa439
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
BioComp Pharma, Inc.
Application
ANDA091396
Marketing category
ANDA
Marketing start
2019-10-28
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 Oral Solution
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIV021NXA9J
Rxcui249066

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
44523-182-082024-02-12C16284748780-11030e365-3470-111a-e063-dadaa90a10e2Prednisolone Sodium Phosphate Oral Solution (25 mg prednisolone base per 5 mL)
44523-182-082024-02-12C16284748780-11030e365-3470-111a-e063-dadaa90a10e2Prednisolone Sodium Phosphate Oral Solution (25 mg prednisolone base per 5 mL)
44523-182-082024-02-12C16284748780-11030e365-3470-111a-e063-dadaa90a10e2Prednisolone Sodium Phosphate Oral Solution (25 mg prednisolone base per 5 mL)
44523-182-082024-01-30C16284748780-11030e365-3470-111a-e063-dadaa90a10e2Prednisolone Sodium Phosphate Oral Solution (25 mg prednisolone base per 5 mL)
44523-182-082024-01-30C16284748780-11030e365-3470-111a-e063-dadaa90a10e2Prednisolone Sodium Phosphate Oral Solution (25 mg prednisolone base per 5 mL)
44523-182-082024-01-30C16284748780-11030e365-3470-111a-e063-dadaa90a10e2Prednisolone Sodium Phosphate Oral Solution (25 mg prednisolone base per 5 mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-182-08Prednisolone Sodium Phosphate Oral Solution237 mL in 1 BOTTLESOLUTION2378

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-182-08ML - Milliliter44523-182ee10045a-9b1a-479e-b54b-018450589c9f12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-182PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (PREDNISOLONE SODIUM PHOSPHATE) SOLUTION [BIOCOMP PHARMA, INC.]6Current NDC, Legacy NDC, 1 package rows20240607_95208441-1700-5d3f-e053-2a95a90a7da2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
249066prednisoLONE sodium phosphate 25 MG in 5 mL Oral SolutionPSN95208441-1700-5d3f-e053-2a95a90a7da28
249066prednisolone 5 MG/ML Oral SolutionSCD95208441-1700-5d3f-e053-2a95a90a7da28
249066prednisolone 25 MG (prednisolone sodium phosphate 33.6 MG) per 5 ML Oral SolutionSY95208441-1700-5d3f-e053-2a95a90a7da28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-182-0844523018208237 mL in 1 BOTTLE (44523-182-08) 237 ml2019-10-280000-00-00NoNoCurrent