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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4BA73M5E37CIPROFLOXACIN HYDROCHLORIDE86393-32-0CIPROFLOXACIN HYDROCHLORIDE
5E8K9I0O4UCIPROFLOXACIN85721-33-1CIPROFLOXACIN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-300-06721890300066 TABLET, FILM COATED in 1 BOTTLE (72189-300-06) 2021-12-03NoNoHistorical
72189-300-207218903002020 TABLET, FILM COATED in 1 BOTTLE (72189-300-20) 2021-12-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CiprofloxacinDirectRx2025-01-20HUMAN PRESCRIPTION DRUG LABEL2