Prednisolone Sodium Phosphate

Product NDC
0121-0759
11-digit product format
001210759
Labeler code
0121
Product ID
0121-0759_07592713-8b0b-47aa-8a7f-848823ff221c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0121-0759-08Prednisolone Sodium Phosphate237 mL in 1 BOTTLESOLUTION23716

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0759-08ML - Milliliter0121-0759739bcb40-cf85-4a4b-a196-2cf1ed5b33af12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISOLONE SODIUM PHOSPHATEACTIVE INGREDIENTIV021NXA9JPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
PrednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
corn syrupINACTIVE INGREDIENT9G5L16BK6NPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
glycerinINACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
potassium phosphate, dibasicINACTIVE INGREDIENTCI71S98N1ZPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
potassium phosphate, monobasicINACTIVE INGREDIENT4J9FJ0HL51PREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
waterINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]20
PREDNISOLONE SODIUM PHOSPHATEACTIVE INGREDIENTIV021NXA9JPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
POTASSIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTCI71S98N1ZPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]4
Prednisolone Sodium PhosphateACTIVE INGREDIENTIV021NXA9JPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
PrednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Corn SyrupINACTIVE INGREDIENT9G5L16BK6NPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Hydroxyethyl Cellulose (140 MPA.S at 5%)INACTIVE INGREDIENT8136Y38GY5PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Potassium Phosphate, DibasicINACTIVE INGREDIENTCI71S98N1ZPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Potassium Phosphate, MonobasicINACTIVE INGREDIENT4J9FJ0HL51PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Saccharin Sodium DihydrateINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Prednisolone Sodium PhosphateACTIVE INGREDIENTIV021NXA9JPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
PrednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5PREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
POTASSIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTCI71S98N1ZPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51PREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
WATERINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SODIUM PHOSPHATE SOLUTION [UNIT DOSE SERVICES]2
Prednisolone Sodium PhosphateACTIVE INGREDIENTIV021NXA9JPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
PrednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
Corn SyrupINACTIVE INGREDIENT9G5L16BK6NPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
Hydroxyethyl Cellulose (140 MPA.S at 5%)INACTIVE INGREDIENT8136Y38GY5PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
Potassium Phosphate, DibasicINACTIVE INGREDIENTCI71S98N1ZPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
Potassium Phosphate, MonobasicINACTIVE INGREDIENT4J9FJ0HL51PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1
WaterINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SODIUM PHOSPHATE SOLUTION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0759PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]14Current NDC, Legacy NDC, 1 package rows20240820_a0d74ae0-7b2d-4d36-9211-c76f5063b5a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN6420303a-f493-45f6-b99c-1f3638894a5926
283077prednisolone 3 MG/ML Oral SolutionSCD6420303a-f493-45f6-b99c-1f3638894a5926
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY6420303a-f493-45f6-b99c-1f3638894a5926
283077prednisolone 15 MG per 5 ML Oral SolutionSY6420303a-f493-45f6-b99c-1f3638894a5926
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
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNa0d74ae0-7b2d-4d36-9211-c76f5063b5a916
283077prednisolone 3 MG/ML Oral SolutionSCDa0d74ae0-7b2d-4d36-9211-c76f5063b5a916
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYa0d74ae0-7b2d-4d36-9211-c76f5063b5a916
283077prednisolone 15 MG per 5 ML Oral SolutionSYa0d74ae0-7b2d-4d36-9211-c76f5063b5a916
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN50d651cc-e417-3b40-e054-00144ff8d46c7
283077prednisolone 3 MG/ML Oral SolutionSCD50d651cc-e417-3b40-e054-00144ff8d46c7
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY50d651cc-e417-3b40-e054-00144ff8d46c7
283077prednisolone 15 MG per 5 ML Oral SolutionSY50d651cc-e417-3b40-e054-00144ff8d46c7
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN93b372f7-b811-4c15-85c4-c6dbac342cb46
283077prednisolone 3 MG/ML Oral SolutionSCD93b372f7-b811-4c15-85c4-c6dbac342cb46
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY93b372f7-b811-4c15-85c4-c6dbac342cb46
283077prednisolone 15 MG per 5 ML Oral SolutionSY93b372f7-b811-4c15-85c4-c6dbac342cb46
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN5b3201f8-fa99-41bf-84c1-4e9355a58ce64
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN14b7f41b-4df1-42cb-bd1b-c74b28de26704
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN06caccd6-07df-4ca5-a5ca-3564bde3192a4
283077prednisolone 3 MG/ML Oral SolutionSCD5b3201f8-fa99-41bf-84c1-4e9355a58ce64
283077prednisolone 3 MG/ML Oral SolutionSCD14b7f41b-4df1-42cb-bd1b-c74b28de26704
283077prednisolone 3 MG/ML Oral SolutionSCD06caccd6-07df-4ca5-a5ca-3564bde3192a4
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY5b3201f8-fa99-41bf-84c1-4e9355a58ce64
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY14b7f41b-4df1-42cb-bd1b-c74b28de26704
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY06caccd6-07df-4ca5-a5ca-3564bde3192a4
283077prednisolone 15 MG per 5 ML Oral SolutionSY06caccd6-07df-4ca5-a5ca-3564bde3192a4
283077prednisolone 15 MG per 5 ML Oral SolutionSY5b3201f8-fa99-41bf-84c1-4e9355a58ce64
283077prednisolone 15 MG per 5 ML Oral SolutionSY14b7f41b-4df1-42cb-bd1b-c74b28de26704
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNf87ce1ba-335e-463d-87d5-9af0206f8f613
283077prednisolone 3 MG/ML Oral SolutionSCDf87ce1ba-335e-463d-87d5-9af0206f8f613
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYf87ce1ba-335e-463d-87d5-9af0206f8f613
283077prednisolone 15 MG per 5 ML Oral SolutionSYf87ce1ba-335e-463d-87d5-9af0206f8f613
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNc85891e4-4eb6-4546-9b68-61d560cbedba2
283077prednisolone 3 MG/ML Oral SolutionSCDc85891e4-4eb6-4546-9b68-61d560cbedba2
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYc85891e4-4eb6-4546-9b68-61d560cbedba2
283077prednisolone 15 MG per 5 ML Oral SolutionSYc85891e4-4eb6-4546-9b68-61d560cbedba2
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNc266e029-808b-42dc-ae5b-e73e2c9d92d81
283077prednisolone 3 MG/ML Oral SolutionSCDc266e029-808b-42dc-ae5b-e73e2c9d92d81
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYc266e029-808b-42dc-ae5b-e73e2c9d92d81
283077prednisolone 15 MG per 5 ML Oral SolutionSYc266e029-808b-42dc-ae5b-e73e2c9d92d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0759-0800121075908237 mL in 1 BOTTLE (0121-0759-08) 237 ml2005-04-250000-00-00NoNoCurrent