FDA.reportPublic FDA data

Prednisolone

Product NDC
62135-250
11-digit product format
621350250
Labeler code
62135
Product ID
62135-250_19febba3-956f-d1a9-e063-6394a90afda5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA040323
Marketing category
ANDA
Marketing start
2022-11-20
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
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
62135-250-24Prednisolone2 in 1 BOXSOLUTION25
62135-250-24Prednisolone10 in 1 TRAYSOLUTION105
62135-250-37Prednisolone240 mL in 1 BOTTLESOLUTION2405
62135-250-45Prednisolone5 mL in 1 CUPSOLUTION55
62135-250-47Prednisolone480 mL in 1 BOTTLESOLUTION4805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-250-24ML - Milliliter62135-2500bd2b1af-466f-4ea0-ac35-43df0ae3e20b12024-09-09
62135-250-37ML - Milliliter62135-250ad50217b-a644-4608-aaa3-15592da83b0b12022-10-06
62135-250-45ML - Milliliter62135-250147d1908-2ae4-495c-b15d-bed4fba63b9812024-09-09
62135-250-47ML - Milliliter62135-2508c523ad6-ef2c-4c52-a6e4-f764a41933f912022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-250PREDNISOLONE (PREDNISOLONE ORAL) SOLUTION [CHARTWELL RX, LLC]5Current NDC, Legacy NDC, 5 package rows20240608_aa40f582-cced-4e6e-90f0-10ab310ab2a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNaa40f582-cced-4e6e-90f0-10ab310ab2a75
283077prednisolone 3 MG/ML Oral SolutionSCDaa40f582-cced-4e6e-90f0-10ab310ab2a75
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYaa40f582-cced-4e6e-90f0-10ab310ab2a75
283077prednisolone 15 MG per 5 ML Oral SolutionSYaa40f582-cced-4e6e-90f0-10ab310ab2a75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-250-24621350250242 TRAY in 1 BOX (62135-250-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-250-45) 2 tray2024-05-31NoNoCurrent
62135-250-3762135025037240 mL in 1 BOTTLE (62135-250-37) 240 ml2022-11-200000-00-00NoNoCurrent
62135-250-45621350250455 mL in 1 CUP5 mlHistorical
62135-250-4762135025047480 mL in 1 BOTTLE (62135-250-47) 480 ml2022-11-200000-00-00NoNoCurrent