FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
50090-3573
11-digit product format
500903573
Labeler code
50090
Product ID
50090-3573_a75ad7b6-461a-42d1-ba7f-895c7697f7e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075593
Marketing category
ANDA
Marketing start
2004-06-09
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
50090-3573-02023-01-30C16284748780-1f386c649-a22f-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
50090-3573-12023-01-30C16284748780-1f386c649-a22f-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
50090-3573-22023-01-30C16284748780-1f386c649-a22f-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
50090-3573-0Ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET, FILM COATED63
50090-3573-1Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED143
50090-3573-2Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3573CIPROFLOXACIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 3 package rows20190430_7e071d73-2139-480c-b964-835d69352044.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN7e071d73-2139-480c-b964-835d693520443
197511ciprofloxacin 250 MG Oral TabletSCD7e071d73-2139-480c-b964-835d693520443
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY7e071d73-2139-480c-b964-835d693520443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3573-0500903573006 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3573-0) 2014-11-280000-00-00NoNoCurrent
50090-3573-15009035730114 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3573-1) 2014-11-280000-00-00NoNoCurrent
50090-3573-25009035730210 TABLET, FILM COATED in 1 BOTTLE (50090-3573-2) 2018-09-070000-00-00NoNoCurrent