FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
50090-5505
11-digit product format
500905505
Labeler code
50090
Product ID
50090-5505_c6647412-096d-483d-9f7b-d24f189e9490
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208921
Marketing category
ANDA
Marketing start
2020-08-12
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
50090-5505-02023-01-30C16284748780-1f386c64a-2d43-0266-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
50090-5505-12023-01-30C16284748780-1f386c64a-2d43-0266-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
50090-5505-22023-01-30C16284748780-1f386c64a-2d43-0266-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
50090-5505-32023-01-30C16284748780-1f386c64a-2d43-0266-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
50090-5505-0Ciprofloxacin6 in 1 BOTTLETABLET, COATED61
50090-5505-1Ciprofloxacin14 in 1 BOTTLETABLET, COATED141
50090-5505-2Ciprofloxacin10 in 1 BOTTLETABLET, COATED101
50090-5505-3Ciprofloxacin3 in 1 BOTTLETABLET, COATED31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5505CIPROFLOXACIN TABLET, COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 4 package rows20210413_8f4d4bbb-a8f5-492f-8b2a-22be57719ac9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN8f4d4bbb-a8f5-492f-8b2a-22be57719ac91
197511ciprofloxacin 250 MG Oral TabletSCD8f4d4bbb-a8f5-492f-8b2a-22be57719ac91
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY8f4d4bbb-a8f5-492f-8b2a-22be57719ac91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5505-0500905505006 TABLET, COATED in 1 BOTTLE (50090-5505-0) 2021-04-070000-00-00NoNoCurrent
50090-5505-15009055050114 TABLET, COATED in 1 BOTTLE (50090-5505-1) 2021-04-070000-00-00NoNoCurrent
50090-5505-25009055050210 TABLET, COATED in 1 BOTTLE (50090-5505-2) 2021-04-070000-00-00NoNoCurrent
50090-5505-3500905505033 TABLET, COATED in 1 BOTTLE (50090-5505-3) 2021-04-070000-00-00NoNoCurrent