FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
53002-2642
11-digit product format
530022642
Labeler code
53002
Product ID
53002-2642_68633ef1-13db-4584-ade5-910b89074810
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
500 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
53002-2642-02025-01-30C16284748780-12cef2736-6168-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
53002-2642-12025-01-30C16284748780-12cef2736-6168-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
53002-2642-22025-01-30C16284748780-12cef2736-6168-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
53002-2642-32025-01-30C16284748780-12cef2736-6168-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
53002-2642-42025-01-30C16284748780-12cef2736-6168-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
53002-2642-52025-01-30C16284748780-12cef2736-6168-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
53002-2642-62025-01-30C16284748780-12cef2736-6168-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
53002-2642-92025-01-30C16284748780-12cef2736-6168-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
53002-2642-0Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED301
53002-2642-1Ciprofloxacin1 in 1 BOTTLETABLET, FILM COATED11
53002-2642-2Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED61
53002-2642-3Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED101
53002-2642-4Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED141
53002-2642-5Ciprofloxacin18 in 1 BOTTLETABLET, FILM COATED181
53002-2642-6Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED201
53002-2642-9Ciprofloxacin28 in 1 BOTTLETABLET, FILM COATED281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2642CIPROFLOXACIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 8 package rows20220331_0769aef5-962b-4f6b-ab4c-80e08cd7a790.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN0769aef5-962b-4f6b-ab4c-80e08cd7a7901
309309ciprofloxacin 500 MG Oral TabletSCD0769aef5-962b-4f6b-ab4c-80e08cd7a7901
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY0769aef5-962b-4f6b-ab4c-80e08cd7a7901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2642-05300226420030 TABLET, FILM COATED in 1 BOTTLE (53002-2642-0) 2022-08-010000-00-00NoNoCurrent
53002-2642-1530022642011 TABLET, FILM COATED in 1 BOTTLE (53002-2642-1) 2022-08-010000-00-00NoNoCurrent
53002-2642-2530022642026 TABLET, FILM COATED in 1 BOTTLE (53002-2642-2) 2022-08-010000-00-00NoNoCurrent
53002-2642-35300226420310 TABLET, FILM COATED in 1 BOTTLE (53002-2642-3) 2022-08-010000-00-00NoNoCurrent
53002-2642-45300226420414 TABLET, FILM COATED in 1 BOTTLE (53002-2642-4) 2022-08-010000-00-00NoNoCurrent
53002-2642-55300226420518 TABLET, FILM COATED in 1 BOTTLE (53002-2642-5) 2022-08-010000-00-00NoNoCurrent
53002-2642-65300226420620 TABLET, FILM COATED in 1 BOTTLE (53002-2642-6) 2022-08-010000-00-00NoNoCurrent
53002-2642-95300226420928 TABLET, FILM COATED in 1 BOTTLE (53002-2642-9) 2022-08-010000-00-00NoNoCurrent