FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
67296-1848
11-digit product format
672961848
Labeler code
67296
Product ID
67296-1848_2c62ea96-679a-d05f-e063-6394a90aa2d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Redpharm Drug
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
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
67296-1848-22025-01-30C16284748780-12cef2736-938f-d83d-e063-dadaa90ab31fThese 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
67296-1848-62025-01-30C16284748780-12cef2736-938f-d83d-e063-dadaa90ab31fThese 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
67296-1848-72025-01-30C16284748780-12cef2736-938f-d83d-e063-dadaa90ab31fThese 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
67296-1848-1Ciprofloxacin10 in 1 BOTTLETABLET, COATED102
67296-1848-2Ciprofloxacin20 in 1 BOTTLETABLET, COATED201
67296-1848-6Ciprofloxacin6 in 1 BOTTLETABLET, COATED61
67296-1848-7Ciprofloxacin14 in 1 BOTTLETABLET, COATED141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1848CIPROFLOXACIN TABLET, COATED [REDPHARM DRUG]2Current NDC, 1 package rows20250124_17435f05-f04d-e792-e063-6294a90af145.zip
67296-1848CIPROFLOXACIN TABLET, COATED [REDPHARM DRUG, INC.]1Current NDC, 3 package rows20230204_f3c3181e-4e52-3070-e053-2a95a90aa92f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN17435f05-f04d-e792-e063-6294a90af1452
309309ciprofloxacin 500 MG Oral TabletSCD17435f05-f04d-e792-e063-6294a90af1452
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY17435f05-f04d-e792-e063-6294a90af1452
309309ciprofloxacin 500 MG Oral TabletPSNf3c3181e-4e52-3070-e053-2a95a90aa92f1
309309ciprofloxacin 500 MG Oral TabletSCDf3c3181e-4e52-3070-e053-2a95a90aa92f1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYf3c3181e-4e52-3070-e053-2a95a90aa92f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67296-1848-16729618480110 TABLET, COATED in 1 BOTTLE (67296-1848-1) 2020-08-12NoNoCurrent
67296-1848-26729618480220 in 1 BOTTLEHistorical
67296-1848-6672961848066 in 1 BOTTLEHistorical
67296-1848-76729618480714 in 1 BOTTLEHistorical