FDA.reportPublic FDA data

ciprofloxacin

Product NDC
66267-716
11-digit product format
662670716
Labeler code
66267
Product ID
66267-716_1fa75bd8-ed9b-d874-e063-6394a90a109b
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
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
66267-716-022024-08-14C16284748780-1f386c64a-048e-0266-e053-dadaa90a7c1aThese 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
66267-716-042024-08-14C16284748780-1f386c64a-048e-0266-e053-dadaa90a7c1aThese 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
66267-716-062024-08-14C16284748780-1f386c64a-048e-0266-e053-dadaa90a7c1aThese 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
66267-716-022023-01-30C16284748780-1f386c64a-048e-0266-e053-dadaa90a7c1aThese 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
66267-716-042023-01-30C16284748780-1f386c64a-048e-0266-e053-dadaa90a7c1aThese 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
66267-716-062023-01-30C16284748780-1f386c64a-048e-0266-e053-dadaa90a7c1aThese 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
66267-716-02ciprofloxacin2 in 1 BOTTLETABLET25
66267-716-04ciprofloxacin4 in 1 BOTTLETABLET45
66267-716-06ciprofloxacin6 in 1 BOTTLETABLET65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-716CIPROFLOXACIN TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20240815_44e5582d-fff1-0ec9-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN44e5582d-fff1-0ec9-e054-00144ff88e885
309309ciprofloxacin 500 MG Oral TabletSCD44e5582d-fff1-0ec9-e054-00144ff88e885
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY44e5582d-fff1-0ec9-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-716-02662670716022 TABLET in 1 BOTTLE (66267-716-02) 2 tablet2016-12-300000-00-00NoNoCurrent
66267-716-04662670716044 TABLET in 1 BOTTLE (66267-716-04) 4 tablet2016-12-300000-00-00NoNoCurrent
66267-716-06662670716066 TABLET in 1 BOTTLE (66267-716-06) 6 tablet2016-12-300000-00-00NoNoCurrent