FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
68071-2335
11-digit product format
680712335
Labeler code
68071
Product ID
68071-2335_b980326a-4a3b-4f1f-e053-2995a90ac959
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharnaceuticals,Inc.
Application
ANDA075593
Marketing category
ANDA
Marketing start
2004-06-09
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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
68071-2335-12023-01-30C16284748780-1f386c649-f31e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
68071-2335-22023-01-30C16284748780-1f386c649-f31e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
68071-2335-32023-01-30C16284748780-1f386c649-f31e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
68071-2335-42023-01-30C16284748780-1f386c649-f31e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
68071-2335-62023-01-30C16284748780-1f386c649-f31e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2335-1Ciprofloxacin21 in 1 BOTTLETABLET, FILM COATED211
68071-2335-2Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED201
68071-2335-3Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED301
68071-2335-4Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED141
68071-2335-6Ciprofloxacin60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2335CIPROFLOXACIN TABLET, FILM COATED [NUCARE PHARNACEUTICALS,INC.]1Legacy NDC, 5 package rows20210124_b9803596-c093-463f-e053-2a95a90a0234.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNb9803596-c093-463f-e053-2a95a90a02341
309309ciprofloxacin 500 MG Oral TabletSCDb9803596-c093-463f-e053-2a95a90a02341
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYb9803596-c093-463f-e053-2a95a90a02341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2335-16807123350121 TABLET, FILM COATED in 1 BOTTLE (68071-2335-1) 2021-01-220000-00-00NoNoCurrent
68071-2335-26807123350220 TABLET, FILM COATED in 1 BOTTLE (68071-2335-2) 2021-01-220000-00-00NoNoCurrent
68071-2335-36807123350330 TABLET, FILM COATED in 1 BOTTLE (68071-2335-3) 2021-01-220000-00-00NoNoCurrent
68071-2335-46807123350414 TABLET, FILM COATED in 1 BOTTLE (68071-2335-4) 2021-01-220000-00-00NoNoCurrent
68071-2335-66807123350660 TABLET, FILM COATED in 1 BOTTLE (68071-2335-6) 2021-01-220000-00-00NoNoCurrent