FDA.reportPublic FDA data

ciprofloxacin

Product NDC
68071-4122
11-digit product format
680714122
Labeler code
68071
Product ID
68071-4122_1a13ecfc-3490-4377-e063-6394a90ad455
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076639
Marketing category
ANDA
Marketing start
2004-09-10
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
68071-4122-12024-06-04C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-22024-06-04C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-32024-06-04C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-42024-06-04C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-62024-06-04C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-72024-06-04C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-12023-01-30C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-22023-01-30C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-32023-01-30C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-42023-01-30C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-62023-01-30C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-72023-01-30C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-32021-02-12C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987
68071-4122-32021-01-29C16284748780-1ba0f9c33-4e6b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4122-1ciprofloxacin10 in 1 BOTTLETABLET107
68071-4122-2ciprofloxacin20 in 1 BOTTLETABLET207
68071-4122-3ciprofloxacin30 in 1 BOTTLETABLET307
68071-4122-4ciprofloxacin14 in 1 BOTTLETABLET147
68071-4122-6ciprofloxacin60 in 1 BOTTLETABLET607
68071-4122-7ciprofloxacin21 in 1 BOTTLETABLET217

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4122CIPROFLOXACIN TABLET [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 6 package rows20240606_5bab9397-b9f3-d309-e053-2991aa0a6612.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN5bab9397-b9f3-d309-e053-2991aa0a66127
309309ciprofloxacin 500 MG Oral TabletSCD5bab9397-b9f3-d309-e053-2991aa0a66127
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY5bab9397-b9f3-d309-e053-2991aa0a66127

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4122-16807141220110 TABLET in 1 BOTTLE (68071-4122-1) 10 tablet2017-10-160000-00-00NoNoCurrent
68071-4122-26807141220220 TABLET in 1 BOTTLE (68071-4122-2) 20 tablet2017-10-160000-00-00NoNoCurrent
68071-4122-36807141220330 TABLET in 1 BOTTLE (68071-4122-3) 30 tablet2017-10-160000-00-00NoNoCurrent
68071-4122-46807141220414 TABLET in 1 BOTTLE (68071-4122-4) 14 tablet2017-10-160000-00-00NoNoCurrent
68071-4122-66807141220660 TABLET in 1 BOTTLE (68071-4122-6) 60 tablet2017-10-160000-00-00NoNoCurrent
68071-4122-76807141220721 TABLET in 1 BOTTLE (68071-4122-7) 21 tablet2017-10-160000-00-00NoNoCurrent