FDA.reportPublic FDA data

Prednisolone Sodium Phosphate

Product NDC
17856-0815
11-digit product format
178560815
Labeler code
17856
Product ID
17856-0815_35cf03f4-200d-5643-e063-6394a90a9e02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA203559
Marketing category
ANDA
Marketing start
2023-10-09
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
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
17856-0815-1Prednisolone Sodium Phosphate5 mL in 1 CUP, UNIT-DOSESOLUTION52
17856-0815-1Prednisolone Sodium Phosphate72 in 1 BOX, UNIT-DOSESOLUTION722
17856-0815-2Prednisolone Sodium Phosphate72 in 1 BOX, UNIT-DOSESOLUTION722
17856-0815-2Prednisolone Sodium Phosphate10 mL in 1 CUP, UNIT-DOSESOLUTION102
17856-0815-3Prednisolone Sodium Phosphate48 in 1 BOX, UNIT-DOSESOLUTION482
17856-0815-3Prednisolone Sodium Phosphate5 mL in 1 SYRINGESOLUTION52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0815-1ML - Milliliter17856-08156ab9f831-325f-425f-89be-c216ceed9a7312025-06-13
17856-0815-2ML - Milliliter17856-0815406c0d0a-d84c-47c6-9e16-41b4071b5fd812025-06-13
17856-0815-3ML - Milliliter17856-0815ce2cef20-2855-4e4c-b46e-5f7deb8ae92612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0815PREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORP.]2Current NDC, 6 package rows20250524_96de9cad-2fb7-4947-87ae-4db57563a83a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN96de9cad-2fb7-4947-87ae-4db57563a83a2
283077prednisolone 3 MG/ML Oral SolutionSCD96de9cad-2fb7-4947-87ae-4db57563a83a2
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY96de9cad-2fb7-4947-87ae-4db57563a83a2
283077prednisolone 15 MG per 5 ML Oral SolutionSY96de9cad-2fb7-4947-87ae-4db57563a83a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-0815-11785608150172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-1) / 5 mL in 1 CUP, UNIT-DOSE2025-01-15NoNoHistorical
17856-0815-21785608150272 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-2) / 10 mL in 1 CUP, UNIT-DOSE2025-01-15NoNoHistorical
17856-0815-31785608150348 SYRINGE in 1 BOX, UNIT-DOSE (17856-0815-3) / 5 mL in 1 SYRINGE48 syringe2025-01-15NoNoHistorical