Pred-Gati-Brom

Manufacturer
Imprimis NJOF, LLC
Effective date
2018-01-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:04:23

Label at a glance#

ProductPred-Gati-Brom
Active ingredientBROMFENAC SODIUM, PREDNISOLONE ACETATE, GATIFLOXACIN
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71384-503-072020-02-12C16284748780-19d75b9d0-ecd4-f424-e053-dadaa90a57ce6316c561-8cd1-fe74-e053-2991aa0aef5f
71384-503-072020-01-31C16284748780-19d75b9d0-ecd4-f424-e053-dadaa90a57ce6316c561-8cd1-fe74-e053-2991aa0aef5f

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71384-503-07ML - Milliliter71384-5035c6e5a07-1a36-4906-a19a-3cb0155fde8c12018-07-03

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71384-50371384-503-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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
638a351f-2b10-fd17-e053-2991aa0ae9a56316c561-8cd1-fe74-e053-2991aa0aef5f2018-01-24Exact identifier
spl id: 638a351f-2b10-fd17-e053-2991aa0ae9a5
spl set id: 6316c561-8cd1-fe74-e053-2991aa0aef5f

Reported adverse events (FAERS/openFDA)#

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