FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
68071-2438
11-digit product format
680712438
Labeler code
68071
Product ID
68071-2438_c4311673-2378-2099-e053-2a95a90ad3f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076558
Marketing category
ANDA
Marketing start
2004-06-09
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
68071-2438-22023-01-30C16284748780-1f386c64a-317f-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
68071-2438-62023-01-30C16284748780-1f386c64a-317f-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
68071-2438-2Ciprofloxacin2 in 1 BOTTLETABLET, FILM COATED21
68071-2438-6Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2438CIPROFLOXACIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20210608_c4311673-23c7-2099-e053-2a95a90ad3f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNc4311673-23c7-2099-e053-2a95a90ad3f11
197511ciprofloxacin 250 MG Oral TabletSCDc4311673-23c7-2099-e053-2a95a90ad3f11
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYc4311673-23c7-2099-e053-2a95a90ad3f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2438-2680712438022 TABLET, FILM COATED in 1 BOTTLE (68071-2438-2) 2021-06-070000-00-00NoNoCurrent
68071-2438-6680712438066 TABLET, FILM COATED in 1 BOTTLE (68071-2438-6) 2021-06-070000-00-00NoNoCurrent