FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
50090-1685
11-digit product format
500901685
Labeler code
50090
Product ID
50090-1685_b4d6a8fb-8639-4a47-9303-9791d2526b5b
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
250 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
50090-1685-02023-01-30C16284748780-1f386c649-f691-0266-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
50090-1685-12023-01-30C16284748780-1f386c649-f691-0266-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
50090-1685-22023-01-30C16284748780-1f386c649-f691-0266-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
50090-1685-32023-01-30C16284748780-1f386c649-f691-0266-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
50090-1685-0Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED612
50090-1685-1Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED1412
50090-1685-2Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED1012
50090-1685-3Ciprofloxacin3 in 1 BOTTLETABLET, FILM COATED312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1685-3EA - Each50090-16853d787993-0f2f-45c0-a95f-42e599aee37312022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1685CIPROFLOXACIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]12Legacy NDC, 4 package rows20211112_d5e8cc10-aa34-436c-bf09-16f0e8fafde2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNd5e8cc10-aa34-436c-bf09-16f0e8fafde212
197511ciprofloxacin 250 MG Oral TabletSCDd5e8cc10-aa34-436c-bf09-16f0e8fafde212
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYd5e8cc10-aa34-436c-bf09-16f0e8fafde212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1685-0500901685006 TABLET, FILM COATED in 1 BOTTLE (50090-1685-0) 2015-02-090000-00-00NoNoCurrent
50090-1685-15009016850114 TABLET, FILM COATED in 1 BOTTLE (50090-1685-1) 2015-02-090000-00-00NoNoCurrent
50090-1685-25009016850210 TABLET, FILM COATED in 1 BOTTLE (50090-1685-2) 2015-02-090000-00-00NoNoCurrent
50090-1685-3500901685033 TABLET, FILM COATED in 1 BOTTLE (50090-1685-3) 2021-09-100000-00-00NoNoCurrent