FDA.reportPublic FDA data

ciprofloxacin

Product NDC
71335-0408
11-digit product format
713350408
Labeler code
71335
Product ID
71335-0408_7d2d3be8-5b23-4e66-be62-cfedd2dbccd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076639
Marketing category
ANDA
Marketing start
2004-09-10
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 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 HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197511

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
71335-0408-02024-05-17C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-12024-05-17C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-22024-05-17C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-32024-05-17C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-42024-05-17C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-52024-05-17C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-62024-05-17C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-72024-05-17C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-82024-05-17C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-92024-05-17C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-02024-01-30C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-12024-01-30C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-22024-01-30C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-32024-01-30C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-42024-01-30C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-52024-01-30C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-62024-01-30C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-72024-01-30C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-82024-01-30C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0408-92024-01-30C16284748780-11030e365-4386-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0408-0ciprofloxacin7 in 1 BOTTLETABLET7102
71335-0408-1ciprofloxacin20 in 1 BOTTLETABLET20102
71335-0408-2ciprofloxacin10 in 1 BOTTLETABLET10102
71335-0408-3ciprofloxacin14 in 1 BOTTLETABLET14102
71335-0408-4ciprofloxacin6 in 1 BOTTLETABLET6102
71335-0408-5ciprofloxacin30 in 1 BOTTLETABLET30102
71335-0408-6ciprofloxacin60 in 1 BOTTLETABLET60102
71335-0408-7ciprofloxacin12 in 1 BOTTLETABLET12102
71335-0408-8ciprofloxacin40 in 1 BOTTLETABLET40102
71335-0408-9ciprofloxacin90 in 1 BOTTLETABLET90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0408-0EA - Each71335-040894ca995a-56ea-4646-a58a-59a7c086389112018-02-20
71335-0408-1EA - Each71335-04086c5776ad-129c-4a32-b8fe-993ad10dba9712018-02-20
71335-0408-2EA - Each71335-0408f49412b2-3976-411c-aa9d-45ba90b172e912018-02-20
71335-0408-3EA - Each71335-040830614058-52d3-4d1b-a236-48dd6071419412018-02-20
71335-0408-4EA - Each71335-04080c63d1fc-c9b2-4ade-87bd-02ea5dddf54312018-02-20
71335-0408-5EA - Each71335-04089c55f7ae-54da-47f7-ab41-8c30b7b179e812018-02-20
71335-0408-6EA - Each71335-04086aff3008-af52-435c-b27c-2f5ac6a2527212018-02-20
71335-0408-7EA - Each71335-0408d33d6601-ad37-46b1-8530-de245c0dbe7d12018-02-20
71335-0408-8EA - Each71335-0408d7b27898-434a-48c1-a777-113b10b105e312018-02-20
71335-0408-9EA - Each71335-0408eee1c48c-d66e-43e1-8143-8e36b6ca010712018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0408CIPROFLOXACIN TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20250331_69df48cc-76b6-428e-891a-c25e07d785f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN69df48cc-76b6-428e-891a-c25e07d785f8102
197511ciprofloxacin 250 MG Oral TabletSCD69df48cc-76b6-428e-891a-c25e07d785f8102
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY69df48cc-76b6-428e-891a-c25e07d785f8102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0408-0713350408007 TABLET in 1 BOTTLE (71335-0408-0) 7 tablet2022-05-040000-00-00NoNoCurrent
71335-0408-17133504080120 TABLET in 1 BOTTLE (71335-0408-1) 20 tablet2022-05-040000-00-00NoNoCurrent
71335-0408-27133504080210 TABLET in 1 BOTTLE (71335-0408-2) 10 tablet2022-05-040000-00-00NoNoCurrent
71335-0408-37133504080314 TABLET in 1 BOTTLE (71335-0408-3) 14 tablet2022-05-040000-00-00NoNoCurrent
71335-0408-4713350408046 TABLET in 1 BOTTLE (71335-0408-4) 6 tablet2022-05-040000-00-00NoNoCurrent
71335-0408-57133504080530 TABLET in 1 BOTTLE (71335-0408-5) 30 tablet2022-05-040000-00-00NoNoCurrent
71335-0408-67133504080660 TABLET in 1 BOTTLE (71335-0408-6) 60 tablet2022-05-040000-00-00NoNoCurrent
71335-0408-77133504080712 TABLET in 1 BOTTLE (71335-0408-7) 12 tablet2022-05-040000-00-00NoNoCurrent
71335-0408-87133504080840 TABLET in 1 BOTTLE (71335-0408-8) 40 tablet2022-05-040000-00-00NoNoCurrent
71335-0408-97133504080990 TABLET in 1 BOTTLE (71335-0408-9) 90 tablet2022-05-040000-00-00NoNoCurrent