PREDNISOLONE

Product NDC
61919-291
11-digit product format
619190291
Labeler code
61919
Product ID
61919-291_9caca164-0e55-7ed3-e053-2995a90a1244
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISOLONE
Dosage form
SOLUTION
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040401
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
PREDNISOLONE
Active strength
15 mg/5mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
61919-291-372023-01-30C16284748780-1f386c64a-2223-0266-e053-dadaa90a7c1aPREDNOSOLONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-291-37PREDNISOLONE240 mL in 1 BOTTLESOLUTION2403

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISOLONEACTIVE INGREDIENT9PHQ9Y1OLMPREDNISOLONE SOLUTION [DIRECT RX]1
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SOLUTION [DIRECT RX]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPREDNISOLONE SOLUTION [DIRECT RX]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPREDNISOLONE SOLUTION [DIRECT RX]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMPREDNISOLONE SOLUTION [DIRECT RX]1
CHERRYINACTIVE INGREDIENTBUC5I9595WPREDNISOLONE SOLUTION [DIRECT RX]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SOLUTION [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPREDNISOLONE SOLUTION [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREDNISOLONE SOLUTION [DIRECT RX]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SOLUTION [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREDNISOLONE SOLUTION [DIRECT RX]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SOLUTION [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554PREDNISOLONE SOLUTION [DIRECT RX]1
WATERINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SOLUTION [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-291PREDNISOLONE SOLUTION [DIRECT RX]3Legacy NDC, 1 package rows20200122_bc518439-dd92-438c-b650-b0b327c53a3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNbc518439-dd92-438c-b650-b0b327c53a3d3
283077prednisolone 3 MG/ML Oral SolutionSCDbc518439-dd92-438c-b650-b0b327c53a3d3
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYbc518439-dd92-438c-b650-b0b327c53a3d3
283077prednisolone 15 MG per 5 ML Oral SolutionSYbc518439-dd92-438c-b650-b0b327c53a3d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-291-3761919029137240 mL in 1 BOTTLE (61919-291-37) 240 ml2015-01-010000-00-00NoNoCurrent