FDA.reportPublic FDA data

prednisolone sodium phosphate

Product NDC
50742-383
11-digit product format
507420383
Labeler code
50742
Product ID
50742-383_ebbc1751-9381-4db1-89ff-ae5a2963fb2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisolone sodium phosphate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
NDA021959
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-09-15
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
10 mg/1
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
Brand name suffix
ODT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISOLONE SODIUM PHOSPHATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIV021NXA9J
Rxcui643123, 643125, 643127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
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
50742-383-06prednisolone sodium phosphateODT6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING61
50742-383-12prednisolone sodium phosphateODT2 in 1 CARTONTABLET, ORALLY DISINTEGRATING21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-383-06EA - Each50742-383c145db65-54f0-4604-8983-6b9eae18d41712025-11-13
50742-383-12EA - Each50742-3834b4e2ace-406f-4bd6-b9e1-d2f3aee637a412025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
643123prednisoLONE sodium phosphate 10 MG Disintegrating Oral TabletPSNebbc1751-9381-4db1-89ff-ae5a2963fb2c1
643125prednisoLONE sodium phosphate 15 MG Disintegrating Oral TabletPSNebbc1751-9381-4db1-89ff-ae5a2963fb2c1
643127prednisoLONE sodium phosphate 30 MG Disintegrating Oral TabletPSNebbc1751-9381-4db1-89ff-ae5a2963fb2c1
643123prednisolone 10 MG Disintegrating Oral TabletSCDebbc1751-9381-4db1-89ff-ae5a2963fb2c1
643125prednisolone 15 MG Disintegrating Oral TabletSCDebbc1751-9381-4db1-89ff-ae5a2963fb2c1
643127prednisolone 30 MG Disintegrating Oral TabletSCDebbc1751-9381-4db1-89ff-ae5a2963fb2c1
643123prednisolone 10 MG (prednisolone sodium phosphate 13.4 MG) Disintegrating Oral TabletSYebbc1751-9381-4db1-89ff-ae5a2963fb2c1
643125prednisolone 15 MG (prednisolone sodium phosphate 20.2 MG) Disintegrating Oral TabletSYebbc1751-9381-4db1-89ff-ae5a2963fb2c1
643127prednisolone 30 MG (as prednisolone sodium phosphate 40.3 MG) Disintegrating Oral TabletSYebbc1751-9381-4db1-89ff-ae5a2963fb2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50742-383-06507420383066 in 1 BLISTER PACKHistorical
50742-383-12507420383122 BLISTER PACK in 1 CARTON (50742-383-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50742-383-06) 2 blister pack2025-09-15NoNoHistorical