FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
68071-2384
11-digit product format
680712384
Labeler code
68071
Product ID
68071-2384_4c261b8a-4e9d-8f10-e063-6394a90a0ab8
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
68071-2384-12023-01-30C16284748780-1f386c64a-17b4-0266-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
68071-2384-22023-01-30C16284748780-1f386c64a-17b4-0266-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
68071-2384-32023-01-30C16284748780-1f386c64a-17b4-0266-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
68071-2384-42023-01-30C16284748780-1f386c64a-17b4-0266-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
68071-2384-52023-01-30C16284748780-1f386c64a-17b4-0266-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
68071-2384-62023-01-30C16284748780-1f386c64a-17b4-0266-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
68071-2384-72023-01-30C16284748780-1f386c64a-17b4-0266-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
68071-2384-82023-01-30C16284748780-1f386c64a-17b4-0266-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
68071-2384-92023-01-30C16284748780-1f386c64a-17b4-0266-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
68071-2384-1Ciprofloxacin10 in 1 BOTTLETABLET, COATED102
68071-2384-2Ciprofloxacin20 in 1 BOTTLETABLET, COATED202
68071-2384-3Ciprofloxacin30 in 1 BOTTLETABLET, COATED302
68071-2384-4Ciprofloxacin14 in 1 BOTTLETABLET, COATED142
68071-2384-5Ciprofloxacin15 in 1 BOTTLETABLET, COATED152
68071-2384-6Ciprofloxacin60 in 1 BOTTLETABLET, COATED602
68071-2384-7Ciprofloxacin21 in 1 BOTTLETABLET, COATED212
68071-2384-8Ciprofloxacin28 in 1 BOTTLETABLET, COATED282
68071-2384-9Ciprofloxacin90 in 1 BOTTLETABLET, COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2384CIPROFLOXACIN TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 9 package rows20210410_bf8d4359-a850-97b7-e053-2a95a90aa66a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNbf8d4359-a850-97b7-e053-2a95a90aa66a2
309309ciprofloxacin 500 MG Oral TabletSCDbf8d4359-a850-97b7-e053-2a95a90aa66a2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYbf8d4359-a850-97b7-e053-2a95a90aa66a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2384-16807123840110 TABLET, COATED in 1 BOTTLE (68071-2384-1) 2021-04-090000-00-00NoNoCurrent
68071-2384-26807123840220 TABLET, COATED in 1 BOTTLE (68071-2384-2) 2021-04-090000-00-00NoNoCurrent
68071-2384-36807123840330 TABLET, COATED in 1 BOTTLE (68071-2384-3) 2021-04-090000-00-00NoNoCurrent
68071-2384-46807123840414 TABLET, COATED in 1 BOTTLE (68071-2384-4) 2021-04-090000-00-00NoNoCurrent
68071-2384-56807123840515 TABLET, COATED in 1 BOTTLE (68071-2384-5) 2021-04-090000-00-00NoNoCurrent
68071-2384-66807123840660 TABLET, COATED in 1 BOTTLE (68071-2384-6) 2021-04-090000-00-00NoNoCurrent
68071-2384-76807123840721 TABLET, COATED in 1 BOTTLE (68071-2384-7) 2021-04-090000-00-00NoNoCurrent
68071-2384-86807123840828 TABLET, COATED in 1 BOTTLE (68071-2384-8) 2021-04-090000-00-00NoNoCurrent
68071-2384-96807123840990 TABLET, COATED in 1 BOTTLE (68071-2384-9) 2021-04-090000-00-00NoNoCurrent