FDA.reportPublic FDA data

Pred-Brom

Manufacturer
ImprimisRx NJ
Effective date
2018-03-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:25:29

Key Label Information#

Other Label Information

STORAGE AND HANDLING SECTION

Store at 20° to 25° C (68° to 77° F)

Label Images#

pb
pb

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BROMFENAC Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
PREDNISOLONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
e42b5738-f3b2-36cb-547c-d658794618bcProduct name220250804
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
4ce8f27b-067c-45ad-b8f6-4b29ec66e497Product name220250115
b81a1117-443d-49e4-a709-58c3c32468afProduct name520241010
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
ee6f8cae-1597-1a7e-3fb9-6aaeba954efeProduct name320150902
8442aba0-7521-47cb-8a4e-c9896f35e8aeProduct name320150317
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
70261-505-032020-01-31C16284748780-19d75b9d0-ed58-f424-e053-dadaa90a57ce66638e3d-e2a9-e7c5-e053-2a91aa0ae8c0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70261-505-03Pred-Brom3.5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS3.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70261-505PRED-BROM (PREDNISOLONE ACETATE-BROMFENAC) SUSPENSION/ DROPS [IMPRIMISRX NJ]1Legacy NDC, 1 package rows20180302_66638e3d-e2a9-e7c5-e053-2a91aa0ae8c0.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70261-50570261-505-03

Ingredients#

Name, UNII, Kind table
NameUNIIKind
BROMFENAC864P0921DWACTIB
PREDNISOLONE ACETATE8B2807733DACTIB

Complete SPL Sections#

STORAGE AND HANDLING SECTION

STORAGE AND HANDLING SECTION

Store at 20° to 25° C (68° to 77° F)

Source Document#

Source XML · Source PDF