FDA.reportPublic FDA data

Prednisolone

Product NDC
58177-910
11-digit product format
581770910
Labeler code
58177
Product ID
58177-910_75b15fab-4e46-4382-8754-8a54d5fa676b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone
Dosage form
SYRUP
Route
ORAL
Labeler
ETHEX Corporation
Application
ANDA040364
Marketing category
ANDA
Marketing start
2004-05-10
Marketing end
0000-00-00
Substance
PREDNISOLONE
Active strength
15 mg/5mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
58177-910-052019-10-21C16284748780-1956f9ecf-dbd8-621f-e053-dbdaa90a74adPrednisolone Syrup, USP 15 mg/5 mL
58177-910-072019-10-21C16284748780-1956f9ecf-dbd8-621f-e053-dbdaa90a74adPrednisolone Syrup, USP 15 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58177-910-05Prednisolone240 mL in 1 BOTTLESYRUP2404
58177-910-07Prednisolone480 mL in 1 BOTTLESYRUP4804

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISOLONEACTIVE INGREDIENT9PHQ9Y1OLMPREDNISOLONE SYRUP [ETHEX CORPORATION]4
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SYRUP [ETHEX CORPORATION]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MPREDNISOLONE SYRUP [ETHEX CORPORATION]4
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMPREDNISOLONE SYRUP [ETHEX CORPORATION]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREDNISOLONE SYRUP [ETHEX CORPORATION]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SYRUP [ETHEX CORPORATION]4
ETHYL MALTOLINACTIVE INGREDIENTL6Q8K29L05PREDNISOLONE SYRUP [ETHEX CORPORATION]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPREDNISOLONE SYRUP [ETHEX CORPORATION]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREDNISOLONE SYRUP [ETHEX CORPORATION]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SYRUP [ETHEX CORPORATION]4
GLYCYRRHIZIN, AMMONIATEDINACTIVE INGREDIENT3VRD35U26CPREDNISOLONE SYRUP [ETHEX CORPORATION]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREDNISOLONE SYRUP [ETHEX CORPORATION]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SYRUP [ETHEX CORPORATION]4
SUCROSEINACTIVE INGREDIENTC151H8M554PREDNISOLONE SYRUP [ETHEX CORPORATION]4
WATERINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SYRUP [ETHEX CORPORATION]4
PREDNISOLONEACTIVE INGREDIENT9PHQ9Y1OLMPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
D&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
ETHYL MALTOLINACTIVE INGREDIENTL6Q8K29L05PREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
GLYCYRRHIZIN, AMMONIATEDINACTIVE INGREDIENT3VRD35U26CPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554PREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SYRUP [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58177-910PREDNISOLONE SYRUP [ETHEX CORPORATION]4Legacy NDC, 2 package rows20100507_cd855c59-940d-4dda-8305-81473cdf8a27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNcd855c59-940d-4dda-8305-81473cdf8a274
283077prednisolone 3 MG/ML Oral SolutionSCDcd855c59-940d-4dda-8305-81473cdf8a274
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYcd855c59-940d-4dda-8305-81473cdf8a274
283077prednisolone 15 MG per 5 ML Oral SolutionSYcd855c59-940d-4dda-8305-81473cdf8a274
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSNb4f7f1e5-c73d-44ed-8c3e-b1771da678d31
312614prednisoLONE sodium phosphate 5 MG in 5 mL Oral SolutionPSNb4f7f1e5-c73d-44ed-8c3e-b1771da678d31
312614prednisolone 1 MG/ML Oral SolutionSCDb4f7f1e5-c73d-44ed-8c3e-b1771da678d31
283077prednisolone 3 MG/ML Oral SolutionSCDb4f7f1e5-c73d-44ed-8c3e-b1771da678d31
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSYb4f7f1e5-c73d-44ed-8c3e-b1771da678d31
283077prednisolone 15 MG per 5 ML Oral SolutionSYb4f7f1e5-c73d-44ed-8c3e-b1771da678d31
312614prednisolone 5 MG (as prednisolone sodium phosphate 6.7 MG) per 5 ML Oral SolutionSYb4f7f1e5-c73d-44ed-8c3e-b1771da678d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
58177-910-0558177091005240 mL in 1 BOTTLE240 mlHistorical
58177-910-0758177091007480 mL in 1 BOTTLE480 mlHistorical