ciprofloxacin

Product NDC
85293-004
11-digit product format
852930004
Labeler code
85293
Product ID
85293-004_2fc39084-df93-4b13-e063-6394a90a38a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Umasuto, LLC
Application
ANDA076639
Marketing category
ANDA
Marketing start
2025-03-05
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
750 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 HYDROCHLORIDE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197511, 197512, 309309

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
85293-004-01ciprofloxacin100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85293-004CIPROFLOXACIN TABLET [UMASUTO, LLC]1Current NDC, 1 package rows20250317_0c355077-7361-41d0-9e82-eb31beaf5daa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN0c355077-7361-41d0-9e82-eb31beaf5daa1
309309ciprofloxacin 500 MG Oral TabletPSN0c355077-7361-41d0-9e82-eb31beaf5daa1
197512ciprofloxacin 750 MG Oral TabletPSN0c355077-7361-41d0-9e82-eb31beaf5daa1
197511ciprofloxacin 250 MG Oral TabletSCD0c355077-7361-41d0-9e82-eb31beaf5daa1
309309ciprofloxacin 500 MG Oral TabletSCD0c355077-7361-41d0-9e82-eb31beaf5daa1
197512ciprofloxacin 750 MG Oral TabletSCD0c355077-7361-41d0-9e82-eb31beaf5daa1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY0c355077-7361-41d0-9e82-eb31beaf5daa1
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY0c355077-7361-41d0-9e82-eb31beaf5daa1
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY0c355077-7361-41d0-9e82-eb31beaf5daa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85293-004-0185293000401100 TABLET in 1 BOTTLE (85293-004-01) 100 tablet2025-03-05NoNoHistorical