ciprofloxacin

Product NDC
55154-0193
11-digit product format
551540193
Labeler code
55154
Product ID
55154-0193_13df5419-1215-42dc-9e13-175c77be88ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076639
Marketing category
ANDA
Marketing start
2025-10-17
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
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 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
55154-0193-0ciprofloxacin1 in 1 BLISTER PACKTABLET, FILM COATED12
55154-0193-0ciprofloxacin10 in 1 BAGTABLET, FILM COATED102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN922e9f5c-cc59-4d9e-bf42-a4b900d077ed2
309309ciprofloxacin 500 MG Oral TabletSCD922e9f5c-cc59-4d9e-bf42-a4b900d077ed2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY922e9f5c-cc59-4d9e-bf42-a4b900d077ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-0193-05515401930010 BLISTER PACK in 1 BAG (55154-0193-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-10-17NoNoCurrent