Prednisolone

Product NDC
62135-437
11-digit product format
621350437
Labeler code
62135
Product ID
62135-437_1b180b1a-f4e2-e1ee-e063-6294a90adc05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA080531
Marketing category
ANDA
Marketing start
1974-05-31
Substance
PREDNISOLONE
Active strength
5 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISOLONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9PHQ9Y1OLM
Rxcui198142

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
62135-437-30Prednisolone30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-437-30EA - Each62135-4376107195f-6e48-472e-b7fb-991879d9980412023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-437PREDNISOLONE TABLET [CHARTWELL RX, LLC]2Current NDC, 1 package rows20240618_2e965355-f7f2-4dd3-9c5c-1524c6f39c91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198142prednisoLONE 5 MG Oral TabletPSN2e965355-f7f2-4dd3-9c5c-1524c6f39c912
198142prednisolone 5 MG Oral TabletSCD2e965355-f7f2-4dd3-9c5c-1524c6f39c912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-437-306213504373030 TABLET in 1 BOTTLE (62135-437-30) 30 tablet2023-03-08NoNoHistorical