FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
53002-2791
11-digit product format
530022791
Labeler code
53002
Product ID
53002-2791_51cb4223-f94f-43ab-9988-4fa2d6d71329
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
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
2023-12-31
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
53002-2791-12025-01-30C16284748780-12cef2736-a1a6-d83d-e063-dadaa90ab31fThese 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
53002-2791-22025-01-30C16284748780-12cef2736-a1a6-d83d-e063-dadaa90ab31fThese 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
53002-2791-32025-01-30C16284748780-12cef2736-a1a6-d83d-e063-dadaa90ab31fThese 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
53002-2791-42025-01-30C16284748780-12cef2736-a1a6-d83d-e063-dadaa90ab31fThese 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
53002-2791-1Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED61
53002-2791-2Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED101
53002-2791-3Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED141
53002-2791-4Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2791CIPROFLOXACIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 4 package rows20220331_8d02d47c-37f7-4d30-ace0-1f986eb2b228.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN8d02d47c-37f7-4d30-ace0-1f986eb2b2281
197511ciprofloxacin 250 MG Oral TabletSCD8d02d47c-37f7-4d30-ace0-1f986eb2b2281
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY8d02d47c-37f7-4d30-ace0-1f986eb2b2281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2791-1530022791016 TABLET, FILM COATED in 1 BOTTLE (53002-2791-1) 2022-08-010000-00-00NoNoCurrent
53002-2791-25300227910210 TABLET, FILM COATED in 1 BOTTLE (53002-2791-2) 2022-08-010000-00-00NoNoCurrent
53002-2791-35300227910314 TABLET, FILM COATED in 1 BOTTLE (53002-2791-3) 2022-08-010000-00-00NoNoCurrent
53002-2791-45300227910420 TABLET, FILM COATED in 1 BOTTLE (53002-2791-4) 2022-08-010000-00-00NoNoCurrent