ciprofloxacin

Product NDC
68788-7500
11-digit product format
687887500
Labeler code
68788
Product ID
68788-7500_bbc3e786-14b4-4048-8c0e-8d00a79e02f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Preferred 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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7500-5ciprofloxacin1 in 1 CARTONSOLUTION17
68788-7500-5ciprofloxacin5 mL in 1 BOTTLE, PLASTICSOLUTION57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7500CIPROFLOXACIN SOLUTION [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20240328_85c48ebc-d94a-4254-86df-d2c1aff09b37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN85c48ebc-d94a-4254-86df-d2c1aff09b377
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD85c48ebc-d94a-4254-86df-d2c1aff09b377
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY85c48ebc-d94a-4254-86df-d2c1aff09b377
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY85c48ebc-d94a-4254-86df-d2c1aff09b377

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7500-5687887500051 BOTTLE, PLASTIC in 1 CARTON (68788-7500-5) / 5 mL in 1 BOTTLE, PLASTIC2019-11-300000-00-00NoNoCurrent