FDA.reportPublic FDA data

Pred-Brom

Manufacturer
Imprimis NJOF, LLC
Effective date
2018-01-19
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:25:19

Label at a glance#

ProductPred-Brom
Active ingredientPREDNISOLONE ACETATE, BROMFENAC SODIUM
Label structure2 sections

Storage and handling

Store at 20° to 25° C (68° to 77° F)

Label contents#

Full prescribing information#

STORAGE AND HANDLING SECTION

Store at 20° to 25° C (68° to 77° F)

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

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
71384-505-032020-01-31C16284748780-19d75b9cf-e4fb-f424-e053-dadaa90a57ce63254869-67d5-0900-e053-2a91aa0af95c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71384-505-03Pred-Brom3.5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS3.52
71384-505-03Pred-Brom20 in 1 BOXSUSPENSION/ DROPS202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71384-505PRED-BROM (PREDNISOLONE ACETATE-BROMFENAC) SUSPENSION/ DROPS [IMPRIMIS NJOF, LLC]2Legacy NDC, 2 package rows20180120_63254869-67d5-0900-e053-2a91aa0af95c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71384-505-03ML - Milliliter71384-5050a526c01-8d80-4c87-97fe-3f7eb94e432e12018-07-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71384-50571384-505-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PREDNISOLONE ACETATE8B2807733DACTIB
BROMFENAC SODIUM8ECV571Y37ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
632b3f47-ae7c-3e64-e053-2991aa0a59f963254869-67d5-0900-e053-2a91aa0af95c2018-01-19Exact identifier
spl id: 632b3f47-ae7c-3e64-e053-2991aa0a59f9
spl set id: 63254869-67d5-0900-e053-2a91aa0af95c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.