FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71335-1024
11-digit product format
713351024
Labeler code
71335
Product ID
71335-1024_c57dfdd8-ae87-448f-9a49-0cee7400c09c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077859
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
2027-01-31
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197512

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
71335-1024-12024-04-15C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-22024-04-15C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-32024-04-15C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-42024-04-15C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-52024-04-15C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-62024-04-15C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-72024-04-15C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-12024-01-30C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-22024-01-30C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-32024-01-30C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-42024-01-30C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-52024-01-30C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-62024-01-30C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987
71335-1024-72024-01-30C16284748780-11030e365-2bd3-111a-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, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1024-1Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED204
71335-1024-2Ciprofloxacin28 in 1 BOTTLETABLET, FILM COATED284
71335-1024-3Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED144
71335-1024-4Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED304
71335-1024-5Ciprofloxacin60 in 1 BOTTLETABLET, FILM COATED604
71335-1024-6Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED104
71335-1024-7Ciprofloxacin90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1024CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 7 package rows20240417_ec43739e-7154-45a7-add7-bfb8fb779be8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197512ciprofloxacin 750 MG Oral TabletPSNec43739e-7154-45a7-add7-bfb8fb779be84
197512ciprofloxacin 750 MG Oral TabletSCDec43739e-7154-45a7-add7-bfb8fb779be84
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSYec43739e-7154-45a7-add7-bfb8fb779be84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1024-17133510240120 TABLET, FILM COATED in 1 BOTTLE (71335-1024-1) 2018-12-282027-01-31NoNoCurrent
71335-1024-27133510240228 TABLET, FILM COATED in 1 BOTTLE (71335-1024-2) 2021-12-282027-01-31NoNoCurrent
71335-1024-37133510240314 TABLET, FILM COATED in 1 BOTTLE (71335-1024-3) 2018-12-102027-01-31NoNoCurrent
71335-1024-47133510240430 TABLET, FILM COATED in 1 BOTTLE (71335-1024-4) 2021-12-282027-01-31NoNoCurrent
71335-1024-57133510240560 TABLET, FILM COATED in 1 BOTTLE (71335-1024-5) 2021-12-282027-01-31NoNoCurrent
71335-1024-67133510240610 TABLET, FILM COATED in 1 BOTTLE (71335-1024-6) 2018-12-112027-01-31NoNoCurrent
71335-1024-77133510240790 TABLET, FILM COATED in 1 BOTTLE (71335-1024-7) 2021-12-282027-01-31NoNoCurrent