FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71335-1229
11-digit product format
713351229
Labeler code
71335
Product ID
71335-1229_7030109d-5ce0-43f1-a5ed-16a3562acd40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208921
Marketing category
ANDA
Marketing start
2019-07-13
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui309309

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
71335-1229-02024-05-20C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-12024-05-20C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-22024-05-20C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-32024-05-20C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-42024-05-20C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-52024-05-20C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-62024-05-20C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-72024-05-20C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-82024-05-20C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-92024-05-20C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-02024-01-30C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-12024-01-30C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-22024-01-30C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-32024-01-30C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-42024-01-30C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-52024-01-30C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-62024-01-30C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-72024-01-30C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-82024-01-30C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-92024-01-30C16284748780-11030e365-48cb-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These 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
71335-1229-0Ciprofloxacin7 in 1 BOTTLETABLET, COATED7102
71335-1229-1Ciprofloxacin14 in 1 BOTTLETABLET, COATED14102
71335-1229-2Ciprofloxacin30 in 1 BOTTLETABLET, COATED30102
71335-1229-3Ciprofloxacin20 in 1 BOTTLETABLET, COATED20102
71335-1229-4Ciprofloxacin60 in 1 BOTTLETABLET, COATED60102
71335-1229-5Ciprofloxacin6 in 1 BOTTLETABLET, COATED6102
71335-1229-6Ciprofloxacin10 in 1 BOTTLETABLET, COATED10102
71335-1229-7Ciprofloxacin28 in 1 BOTTLETABLET, COATED28102
71335-1229-8Ciprofloxacin100 in 1 BOTTLETABLET, COATED100102
71335-1229-9Ciprofloxacin40 in 1 BOTTLETABLET, COATED40102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1229CIPROFLOXACIN (CIPROFLOXACIN TABLETS) TABLET, COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20250224_7030109d-5ce0-43f1-a5ed-16a3562acd40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN7030109d-5ce0-43f1-a5ed-16a3562acd40102
309309ciprofloxacin 500 MG Oral TabletSCD7030109d-5ce0-43f1-a5ed-16a3562acd40102
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY7030109d-5ce0-43f1-a5ed-16a3562acd40102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1229-0713351229007 TABLET, COATED in 1 BOTTLE (71335-1229-0) 2025-01-300000-00-00NoNoCurrent
71335-1229-17133512290114 TABLET, COATED in 1 BOTTLE (71335-1229-1) 2025-01-300000-00-00NoNoCurrent
71335-1229-27133512290230 TABLET, COATED in 1 BOTTLE (71335-1229-2) 2019-09-090000-00-00NoNoCurrent
71335-1229-37133512290320 TABLET, COATED in 1 BOTTLE (71335-1229-3) 2025-01-300000-00-00NoNoCurrent
71335-1229-47133512290460 TABLET, COATED in 1 BOTTLE (71335-1229-4) 2025-01-300000-00-00NoNoCurrent
71335-1229-5713351229056 TABLET, COATED in 1 BOTTLE (71335-1229-5) 2019-07-190000-00-00NoNoCurrent
71335-1229-67133512290610 TABLET, COATED in 1 BOTTLE (71335-1229-6) 2025-01-300000-00-00NoNoCurrent
71335-1229-77133512290728 TABLET, COATED in 1 BOTTLE (71335-1229-7) 2025-01-300000-00-00NoNoCurrent
71335-1229-871335122908100 TABLET, COATED in 1 BOTTLE (71335-1229-8) 2025-01-300000-00-00NoNoCurrent
71335-1229-97133512290940 TABLET, COATED in 1 BOTTLE (71335-1229-9) 2025-01-300000-00-00NoNoCurrent