FDA.reportPublic FDA data

Prednisolone

Product NDC
23155-927
11-digit product format
231550927
Labeler code
23155
Product ID
23155-927_d2e4ebab-8c9d-44cb-b665-293007f7e058
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisolone oral solution
Dosage form
SOLUTION
Route
ORAL
Labeler
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
Application
ANDA040323
Marketing category
ANDA
Marketing start
2025-03-01
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
23155-927-51Prednisolone240 mL in 1 BOTTLESOLUTION2401
23155-927-52Prednisolone480 mL in 1 BOTTLESOLUTION4801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-927-51ML - Milliliter23155-9275fd2093d-1d81-4d6b-849d-240f2e65861012025-06-13
23155-927-52ML - Milliliter23155-92700b02465-dd6f-4069-b645-b0d9839d334512025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-927PREDNISOLONE (PREDNISOLONE ORAL SOLUTION) SOLUTION [HERITAGE PHARMA LABS INC. D/B/A AVET PHARMACEUTICALS LABS INC.]1Current NDC, 2 package rows20250302_b079834f-9aa3-4db9-bd53-de28e8f81c04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNb079834f-9aa3-4db9-bd53-de28e8f81c041
283077prednisolone 3 MG/ML Oral SolutionSCDb079834f-9aa3-4db9-bd53-de28e8f81c041
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYb079834f-9aa3-4db9-bd53-de28e8f81c041
283077prednisolone 15 MG per 5 ML Oral SolutionSYb079834f-9aa3-4db9-bd53-de28e8f81c041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-927-5123155092751240 mL in 1 BOTTLE (23155-927-51) 240 ml2025-03-01NoNoCurrent
23155-927-5223155092752480 mL in 1 BOTTLE (23155-927-52) 480 ml2025-03-01NoNoCurrent