FDA.reportPublic FDA data

Prednisolone Sodium Phosphate

Product NDC
0121-0777
11-digit product format
001210777
Labeler code
0121
Product ID
0121-0777_1b34fa45-5c3c-4a81-98be-0fbe2463c3d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA078988
Marketing category
ANDA
Marketing start
2017-01-31
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
20 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 PHOSPHATE20 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIV021NXA9J
Rxcui702306

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
0121-0777-08Prednisolone Sodium Phosphate237 mL in 1 BOTTLESOLUTION2378

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0777-08ML - Milliliter0121-0777d100bb21-0a54-4dfa-940e-922f1d89090612017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0777PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]8Current NDC, Legacy NDC, 1 package rows20250213_acc8badf-d9fd-4f99-a650-a149138b68b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702306prednisoLONE sodium phosphate 20 MG in 5 mL Oral SolutionPSNacc8badf-d9fd-4f99-a650-a149138b68b18
702306prednisolone 4 MG/ML Oral SolutionSCDacc8badf-d9fd-4f99-a650-a149138b68b18
702306prednisolone 20 MG (as prednisolone sodium phosphate 26.9 MG) per 5 ML Oral SolutionSYacc8badf-d9fd-4f99-a650-a149138b68b18
702306prednisoLONE sodium phosphate 20 MG in 5 mL Oral SolutionPSN1d247de0-f2e2-43a6-8698-1b2ea6b442601
702306prednisoLONE sodium phosphate 20 MG in 5 mL Oral SolutionPSN2162943d-15a8-49bd-8717-f728a6808e031
702306prednisolone 4 MG/ML Oral SolutionSCD1d247de0-f2e2-43a6-8698-1b2ea6b442601
702306prednisolone 4 MG/ML Oral SolutionSCD2162943d-15a8-49bd-8717-f728a6808e031
702306prednisolone 20 MG (as prednisolone sodium phosphate 26.9 MG) per 5 ML Oral SolutionSY1d247de0-f2e2-43a6-8698-1b2ea6b442601
702306prednisolone 20 MG (as prednisolone sodium phosphate 26.9 MG) per 5 ML Oral SolutionSY2162943d-15a8-49bd-8717-f728a6808e031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0777-0800121077708237 mL in 1 BOTTLE (0121-0777-08) 237 ml2017-01-310000-00-00NoNoCurrent