FDA.reportPublic FDA data

ciprofloxacin

Product NDC
68071-4260
11-digit product format
680714260
Labeler code
68071
Product ID
68071-4260_1a3c49be-c43a-da6c-e063-6394a90a39bf
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
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
68071-4260-22024-06-06C16284748780-1ba0f9c33-402d-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
68071-4260-32024-06-06C16284748780-1ba0f9c33-402d-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
68071-4260-42024-06-06C16284748780-1ba0f9c33-402d-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
68071-4260-52024-06-06C16284748780-1ba0f9c33-402d-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
68071-4260-62024-06-06C16284748780-1ba0f9c33-402d-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
68071-4260-72024-06-06C16284748780-1ba0f9c33-402d-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
68071-4260-82024-06-06C16284748780-1ba0f9c33-402d-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
68071-4260-92024-06-06C16284748780-1ba0f9c33-402d-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
68071-4260-22023-01-30C16284748780-1ba0f9c33-402d-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
68071-4260-32023-01-30C16284748780-1ba0f9c33-402d-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
68071-4260-42023-01-30C16284748780-1ba0f9c33-402d-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
68071-4260-52023-01-30C16284748780-1ba0f9c33-402d-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
68071-4260-62023-01-30C16284748780-1ba0f9c33-402d-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
68071-4260-72023-01-30C16284748780-1ba0f9c33-402d-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
68071-4260-82023-01-30C16284748780-1ba0f9c33-402d-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
68071-4260-92023-01-30C16284748780-1ba0f9c33-402d-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
68071-4260-22021-02-10C16284748780-1ba0f9c33-402d-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
68071-4260-32021-02-10C16284748780-1ba0f9c33-402d-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
68071-4260-42021-02-10C16284748780-1ba0f9c33-402d-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
68071-4260-52021-02-10C16284748780-1ba0f9c33-402d-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
68071-4260-62021-02-10C16284748780-1ba0f9c33-402d-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
68071-4260-72021-02-10C16284748780-1ba0f9c33-402d-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
68071-4260-82021-02-10C16284748780-1ba0f9c33-402d-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
68071-4260-92021-02-10C16284748780-1ba0f9c33-402d-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
68071-4260-22021-01-29C16284748780-1ba0f9c33-402d-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
68071-4260-32021-01-29C16284748780-1ba0f9c33-402d-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
68071-4260-42021-01-29C16284748780-1ba0f9c33-402d-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
68071-4260-52021-01-29C16284748780-1ba0f9c33-402d-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
68071-4260-62021-01-29C16284748780-1ba0f9c33-402d-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
68071-4260-72021-01-29C16284748780-1ba0f9c33-402d-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
68071-4260-82021-01-29C16284748780-1ba0f9c33-402d-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
68071-4260-92021-01-29C16284748780-1ba0f9c33-402d-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
68071-4260-2ciprofloxacin21 in 1 BOTTLETABLET214
68071-4260-3ciprofloxacin30 in 1 BOTTLETABLET304
68071-4260-4ciprofloxacin14 in 1 BOTTLETABLET144
68071-4260-5ciprofloxacin20 in 1 BOTTLETABLET204
68071-4260-6ciprofloxacin6 in 1 BOTTLETABLET64
68071-4260-7ciprofloxacin10 in 1 BOTTLETABLET104
68071-4260-8ciprofloxacin28 in 1 BOTTLETABLET284
68071-4260-9ciprofloxacin90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4260CIPROFLOXACIN TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 8 package rows20240608_641729a3-6dd3-3a2f-e053-2991aa0a015e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN641729a3-6dd3-3a2f-e053-2991aa0a015e4
197511ciprofloxacin 250 MG Oral TabletSCD641729a3-6dd3-3a2f-e053-2991aa0a015e4
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY641729a3-6dd3-3a2f-e053-2991aa0a015e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4260-26807142600221 TABLET in 1 BOTTLE (68071-4260-2) 21 tablet2018-01-310000-00-00NoNoCurrent
68071-4260-36807142600330 TABLET in 1 BOTTLE (68071-4260-3) 30 tablet2018-01-310000-00-00NoNoCurrent
68071-4260-46807142600414 TABLET in 1 BOTTLE (68071-4260-4) 14 tablet2018-01-310000-00-00NoNoCurrent
68071-4260-56807142600520 TABLET in 1 BOTTLE (68071-4260-5) 20 tablet2018-01-310000-00-00NoNoCurrent
68071-4260-6680714260066 TABLET in 1 BOTTLE (68071-4260-6) 6 tablet2018-01-310000-00-00NoNoCurrent
68071-4260-76807142600710 TABLET in 1 BOTTLE (68071-4260-7) 10 tablet2018-01-310000-00-00NoNoCurrent
68071-4260-86807142600828 TABLET in 1 BOTTLE (68071-4260-8) 28 tablet2018-01-310000-00-00NoNoCurrent
68071-4260-96807142600990 TABLET in 1 BOTTLE (68071-4260-9) 90 tablet2018-01-310000-00-00NoNoCurrent