FDA.reportPublic FDA data

ciprofloxacin

Product NDC
68071-4679
11-digit product format
680714679
Labeler code
68071
Product ID
68071-4679_1ab8822b-544e-2350-e063-6394a90ac9a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077568
Marketing category
ANDA
Marketing start
2018-11-01
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
3 mg/mL
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 HYDROCHLORIDE3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui309307

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4679-52024-02-05C16284748780-1ba0f9c33-258d-a910-e053-dadaa90a0b85Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile
68071-4679-52023-01-30C16284748780-1ba0f9c33-258d-a910-e053-dadaa90a0b85Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile
68071-4679-52021-02-17C16284748780-1ba0f9c33-258d-a910-e053-dadaa90a0b85Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile
68071-4679-52021-01-29C16284748780-1ba0f9c33-258d-a910-e053-dadaa90a0b85Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4679-5ciprofloxacin5 mL in 1 BOTTLESOLUTION56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4679CIPROFLOXACIN SOLUTION [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 1 package rows20240614_7def5a45-6725-0521-e053-2991aa0a0bda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN7def5a45-6725-0521-e053-2991aa0a0bda6
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD7def5a45-6725-0521-e053-2991aa0a0bda6
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY7def5a45-6725-0521-e053-2991aa0a0bda6
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY7def5a45-6725-0521-e053-2991aa0a0bda6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4679-5680714679055 mL in 1 BOTTLE (68071-4679-5) 5 ml2018-12-260000-00-00NoNoCurrent