FDA.reportPublic FDA data

CIPROFLOXACIN

Product NDC
72189-300
11-digit product format
721890300
Labeler code
72189
Product ID
72189-300_2c294bda-345b-ad0e-e063-6294a90a0304
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIPROFLOXACIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRx
Application
ANDA076558
Marketing category
ANDA
Marketing start
2021-12-03
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-300-06CIPROFLOXACIN6 in 1 BOTTLETABLET, FILM COATED62
72189-300-20CIPROFLOXACIN20 in 1 BOTTLETABLET, FILM COATED202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-300-06EA - Each72189-30021b72457-9e7f-4597-a21a-08f4f87053f312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-300CIPROFLOXACIN TABLET, FILM COATED [DIRECTRX]2Current NDC, Legacy NDC, 2 package rows20250121_d23e359d-6d12-38f6-e053-2a95a90a0a88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNd23e359d-6d12-38f6-e053-2a95a90a0a882
309309ciprofloxacin 500 MG Oral TabletSCDd23e359d-6d12-38f6-e053-2a95a90a0a882
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd23e359d-6d12-38f6-e053-2a95a90a0a882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-300-06721890300066 TABLET, FILM COATED in 1 BOTTLE (72189-300-06) 2021-12-030000-00-00NoNoCurrent
72189-300-207218903002020 TABLET, FILM COATED in 1 BOTTLE (72189-300-20) 2021-12-030000-00-00NoNoCurrent