FDA.reportPublic FDA data

Prednisolone

Product NDC
67296-1656
Requested package NDC
67296-1656-6
11-digit product format
672961656
Labeler code
67296
Product ID
67296-1656_1f3e9f53-9ced-a048-e063-6294a90ae1a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone
Dosage form
SOLUTION
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040401
Marketing category
ANDA
Marketing start
2003-02-27
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-165667296-1656-6IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040401-001PREDNISOLONEPREDNISOLONE15MG/5MLSOLUTION / ORAL2003-02-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040401-001PREDNISOLONE15MG/5MLSOLUTION / ORAL2003-02-27a50c72e98297…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1656-62024-08-09C16284748780-11030e365-5f01-111a-e063-dadaa90a10e2PREDNISOLONE ORAL SOLUTION 15 mg per 5 mL
67296-1656-62024-01-30C16284748780-11030e365-5f01-111a-e063-dadaa90a10e2PREDNISOLONE ORAL SOLUTION 15 mg per 5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1656-6Prednisolone60 mL in 1 BOTTLESOLUTION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1656PREDNISOLONE SOLUTION [REDPHARM DRUG, INC.]3Current NDC, Legacy NDC, 1 package rows20240810_b339a007-6a1e-6578-e053-2995a90a53d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNb339a007-6a1e-6578-e053-2995a90a53d03
283077prednisolone 3 MG/ML Oral SolutionSCDb339a007-6a1e-6578-e053-2995a90a53d03
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYb339a007-6a1e-6578-e053-2995a90a53d03
283077prednisolone 15 MG per 5 ML Oral SolutionSYb339a007-6a1e-6578-e053-2995a90a53d03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1656-66729616560660 mL in 1 BOTTLE (67296-1656-6) 60 ml2003-02-270000-00-00NoNoCurrent