PREDNISOLONE ACETATE

Product NDC
72189-055
11-digit product format
721890055
Labeler code
72189
Product ID
72189-055_96232353-7a99-374d-e053-2a95a90a0569
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISOLONE ACETATE
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
DIRECT RX
Application
NDA017469
Marketing category
NDA
Marketing start
2019-10-30
Marketing end
0000-00-00
Substance
PREDNISOLONE ACETATE
Active strength
10 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-055-052023-01-30C16284748780-1f386c64a-008d-0266-e053-dadaa90a7c1aPREDNISOLONE ACETATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-055-05PREDNISOLONE ACETATE1 mL in 1 BOTTLESUSPENSION/ DROPS11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-055-05ML - Milliliter72189-055555e5496-0b15-4d1a-a3de-56cbd34a1cb412019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-055PREDNISOLONE ACETATE SUSPENSION/ DROPS [DIRECT RX]1Legacy NDC, 1 package rows20191123_96232353-7a98-374d-e053-2a95a90a0569.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN96232353-7a98-374d-e053-2a95a90a05691
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD96232353-7a98-374d-e053-2a95a90a05691
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY96232353-7a98-374d-e053-2a95a90a05691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-055-05721890055051 mL in 1 BOTTLE (72189-055-05) 1 ml2019-10-300000-00-00NoNoCurrent