FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
50090-5382
11-digit product format
500905382
Labeler code
50090
Product ID
50090-5382_ab0ce09c-f027-45ee-a24a-37f068c82f55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076794
Marketing category
ANDA
Marketing start
2006-11-01
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
2021-12-31
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
50090-5382-02023-01-30C16284748780-1f386c649-c66f-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 tablet s , for oral use Initial U.S. Approval: 1987
50090-5382-12023-01-30C16284748780-1f386c649-c66f-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 tablet s , for oral use Initial U.S. Approval: 1987
50090-5382-32023-01-30C16284748780-1f386c649-c66f-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 tablet s , for oral use Initial U.S. Approval: 1987
50090-5382-42023-01-30C16284748780-1f386c649-c66f-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 tablet s , for oral use Initial U.S. Approval: 1987
50090-5382-52023-01-30C16284748780-1f386c649-c66f-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 tablet s , for oral use Initial U.S. Approval: 1987
50090-5382-72023-01-30C16284748780-1f386c649-c66f-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 tablet s , for oral use Initial U.S. Approval: 1987
50090-5382-82023-01-30C16284748780-1f386c649-c66f-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 tablet s , for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5382-0Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED201
50090-5382-1Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED141
50090-5382-3Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED61
50090-5382-4Ciprofloxacin28 in 1 BOTTLETABLET, FILM COATED281
50090-5382-5Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED101
50090-5382-7Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED301
50090-5382-8Ciprofloxacin1 in 1 BOTTLETABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5382CIPROFLOXACIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 7 package rows20201216_cc67ac0a-91b9-4867-a88d-b798e660f33b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNcc67ac0a-91b9-4867-a88d-b798e660f33b1
309309ciprofloxacin 500 MG Oral TabletSCDcc67ac0a-91b9-4867-a88d-b798e660f33b1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYcc67ac0a-91b9-4867-a88d-b798e660f33b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5382-05009053820020 TABLET, FILM COATED in 1 BOTTLE (50090-5382-0) 2020-11-200000-00-00NoNoCurrent
50090-5382-15009053820114 TABLET, FILM COATED in 1 BOTTLE (50090-5382-1) 2020-11-200000-00-00NoNoCurrent
50090-5382-3500905382036 TABLET, FILM COATED in 1 BOTTLE (50090-5382-3) 2020-11-200000-00-00NoNoCurrent
50090-5382-45009053820428 TABLET, FILM COATED in 1 BOTTLE (50090-5382-4) 2020-11-200000-00-00NoNoCurrent
50090-5382-55009053820510 TABLET, FILM COATED in 1 BOTTLE (50090-5382-5) 2020-11-200000-00-00NoNoCurrent
50090-5382-75009053820730 TABLET, FILM COATED in 1 BOTTLE (50090-5382-7) 2020-11-200000-00-00NoNoCurrent
50090-5382-8500905382081 TABLET, FILM COATED in 1 BOTTLE (50090-5382-8) 2020-11-200000-00-00NoNoCurrent