FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71335-1393
11-digit product format
713351393
Labeler code
71335
Product ID
71335-1393_bc284b3d-8ccb-4df6-b3d0-b41e22095fa3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076794
Marketing category
ANDA
Marketing start
2006-11-01
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1393-12024-01-30C16284748780-11030e365-6b8e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987
71335-1393-22024-01-30C16284748780-11030e365-6b8e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987
71335-1393-32024-01-30C16284748780-11030e365-6b8e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987
71335-1393-42024-01-30C16284748780-11030e365-6b8e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987
71335-1393-52024-01-30C16284748780-11030e365-6b8e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987
71335-1393-62024-01-30C16284748780-11030e365-6b8e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987
71335-1393-72024-01-30C16284748780-11030e365-6b8e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1393-1Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED203
71335-1393-2Ciprofloxacin28 in 1 BOTTLETABLET, FILM COATED283
71335-1393-3Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED143
71335-1393-4Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED303
71335-1393-5Ciprofloxacin60 in 1 BOTTLETABLET, FILM COATED603
71335-1393-6Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED103
71335-1393-7Ciprofloxacin90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1393CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]3Legacy NDC, 7 package rows20220513_e659af2b-b240-4afe-894e-962ae9c3d87f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197512ciprofloxacin 750 MG Oral TabletPSNe659af2b-b240-4afe-894e-962ae9c3d87f3
197512ciprofloxacin 750 MG Oral TabletSCDe659af2b-b240-4afe-894e-962ae9c3d87f3
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSYe659af2b-b240-4afe-894e-962ae9c3d87f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1393-17133513930120 TABLET, FILM COATED in 1 BOTTLE (71335-1393-1) 2019-11-080000-00-00NoNoCurrent
71335-1393-27133513930228 TABLET, FILM COATED in 1 BOTTLE (71335-1393-2) 2010-01-180000-00-00NoNoCurrent
71335-1393-37133513930314 TABLET, FILM COATED in 1 BOTTLE (71335-1393-3) 2010-01-180000-00-00NoNoCurrent
71335-1393-47133513930430 TABLET, FILM COATED in 1 BOTTLE (71335-1393-4) 2022-05-020000-00-00NoNoCurrent
71335-1393-57133513930560 TABLET, FILM COATED in 1 BOTTLE (71335-1393-5) 2022-05-020000-00-00NoNoCurrent
71335-1393-67133513930610 TABLET, FILM COATED in 1 BOTTLE (71335-1393-6) 2019-11-110000-00-00NoNoCurrent
71335-1393-77133513930790 TABLET, FILM COATED in 1 BOTTLE (71335-1393-7) 2022-05-020000-00-00NoNoCurrent