FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
68071-2404
11-digit product format
680712404
Labeler code
68071
Product ID
68071-2404_4db9cd04-2a0e-0192-e063-6294a90abd06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208921
Marketing category
ANDA
Marketing start
2020-08-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin
Listing expiration
2027-12-31

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
68071-2404-22023-01-30C16284748780-1f386c649-b8cd-0266-e053-dadaa90a7c1aThese 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
68071-2404-42023-01-30C16284748780-1f386c649-b8cd-0266-e053-dadaa90a7c1aThese 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
68071-2404-62023-01-30C16284748780-1f386c649-b8cd-0266-e053-dadaa90a7c1aThese 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
68071-2404-2Ciprofloxacin2 in 1 BOTTLETABLET, COATED22
68071-2404-4Ciprofloxacin4 in 1 BOTTLETABLET, COATED42
68071-2404-6Ciprofloxacin6 in 1 BOTTLETABLET, COATED62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2404CIPROFLOXACIN TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 3 package rows20210522_c2d8dcc9-23b0-75bb-e053-2995a90a02c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNc2d8dcc9-23b0-75bb-e053-2995a90a02c82
309309ciprofloxacin 500 MG Oral TabletSCDc2d8dcc9-23b0-75bb-e053-2995a90a02c82
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYc2d8dcc9-23b0-75bb-e053-2995a90a02c82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2404-2680712404022 TABLET, COATED in 1 BOTTLE (68071-2404-2) 2021-05-210000-00-00NoNoCurrent
68071-2404-4680712404044 TABLET, COATED in 1 BOTTLE (68071-2404-4) 2021-05-210000-00-00NoNoCurrent
68071-2404-6680712404066 TABLET, COATED in 1 BOTTLE (68071-2404-6) 2021-05-210000-00-00NoNoCurrent