Prednisolone Sodium Phosphate

Product NDC
68999-330
11-digit product format
689990330
Labeler code
68999
Product ID
68999-330_453ad2a6-3423-b21b-e063-6294a90abb44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisolone sodium phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Application
ANDA075988
Marketing category
ANDA
Marketing start
2004-05-25
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
5 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 PHOSPHATE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIV021NXA9J
Rxcui312614

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
68999-330-05Prednisolone Sodium Phosphate5 mL in 1 CUPSOLUTION51
68999-330-24Prednisolone Sodium Phosphate10 in 1 TRAYSOLUTION101
68999-330-24Prednisolone Sodium Phosphate2 in 1 BOXSOLUTION21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-330-05ML - Milliliter68999-330de362525-8aef-4b12-9c6a-4af68b1d53cd12026-04-20
68999-330-24ML - Milliliter68999-33054431ec2-fc44-431b-b643-ee1d39c7ae7812026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312614prednisoLONE sodium phosphate 5 MG in 5 mL Oral SolutionPSN5ec401b5-132a-4cd2-8c24-6a5c8b63c2f91
312614prednisolone 1 MG/ML Oral SolutionSCD5ec401b5-132a-4cd2-8c24-6a5c8b63c2f91
312614prednisolone 5 MG (as prednisolone sodium phosphate 6.7 MG) per 5 ML Oral SolutionSY5ec401b5-132a-4cd2-8c24-6a5c8b63c2f91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-330-05689990330055 mL in 1 CUP5 mlHistorical
68999-330-24689990330242 TRAY in 1 BOX (68999-330-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-330-05) 2 tray2025-11-26NoNoHistorical