FDA.reportPublic FDA data

PrednisoLONE

Product NDC
0527-5406
11-digit product format
005275406
Labeler code
0527
Product ID
0527-5406_5122ba73-5783-49f0-9b9c-a03d59d8899c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone
Dosage form
SYRUP
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA040775
Marketing category
ANDA
Marketing start
2007-09-21
Substance
PREDNISOLONE
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISOLONE15 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9PHQ9Y1OLM
Rxcui283077

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
0527-5406-68PrednisoLONE240 mL in 1 BOTTLESYRUP24010
0527-5406-70PrednisoLONE480 mL in 1 BOTTLESYRUP48010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-5406-68ML - Milliliter0527-54063ebef26f-c6d4-4336-ab4b-8237249ad58312025-05-14
0527-5406-70ML - Milliliter0527-540602ae935a-39a7-4621-98f9-43a1350945f212025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-5406PREDNISOLONE SYRUP [LANNETT COMPANY, INC.]10Current NDC, Legacy NDC, 2 package rows20240302_86652e2d-664a-4388-a611-c2a9aa4a4bc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN86652e2d-664a-4388-a611-c2a9aa4a4bc810
283077prednisolone 3 MG/ML Oral SolutionSCD86652e2d-664a-4388-a611-c2a9aa4a4bc810
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY86652e2d-664a-4388-a611-c2a9aa4a4bc810
283077prednisolone 15 MG per 5 ML Oral SolutionSY86652e2d-664a-4388-a611-c2a9aa4a4bc810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-5406-6800527540668240 mL in 1 BOTTLE (0527-5406-68) 240 ml2007-09-210000-00-00NoNoCurrent
0527-5406-7000527540670480 mL in 1 BOTTLE (0527-5406-70) 480 ml2007-09-210000-00-00NoNoCurrent