FDA.reportPublic FDA data

Ciprofloxacin Hydrochloride

Product NDC
82804-260
11-digit product format
828040260
Labeler code
82804
Product ID
82804-260_37eb319b-93c5-4bc5-a580-13d0d3ab3cd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076593
Marketing category
ANDA
Marketing start
2024-05-23
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 Hydrochloride
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
82804-260-07Ciprofloxacin Hydrochloride7 in 1 BOTTLETABLET, FILM COATED73
82804-260-10Ciprofloxacin Hydrochloride10 in 1 BOTTLETABLET, FILM COATED103
82804-260-14Ciprofloxacin Hydrochloride14 in 1 BOTTLETABLET, FILM COATED143
82804-260-20Ciprofloxacin Hydrochloride20 in 1 BOTTLETABLET, FILM COATED203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNb281a5c0-5f3e-4e6f-86ac-ed7794aac64c3
309309ciprofloxacin 500 MG Oral TabletSCDb281a5c0-5f3e-4e6f-86ac-ed7794aac64c3
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYb281a5c0-5f3e-4e6f-86ac-ed7794aac64c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-260-07828040260077 TABLET, FILM COATED in 1 BOTTLE (82804-260-07) 2026-04-20NoNoCurrent
82804-260-108280402601010 TABLET, FILM COATED in 1 BOTTLE (82804-260-10) 2026-03-12NoNoCurrent
82804-260-148280402601414 TABLET, FILM COATED in 1 BOTTLE (82804-260-14) 2025-12-30NoNoCurrent
82804-260-208280402602020 TABLET, FILM COATED in 1 BOTTLE (82804-260-20) 2025-12-30NoNoCurrent