FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
42708-002
11-digit product format
427080002
Labeler code
42708
Product ID
42708-002_f11841a1-7e0d-1fb9-e053-2995a90a51d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma Inc
Application
ANDA076794
Marketing category
ANDA
Marketing start
2006-11-01
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42708-002-142021-03-12C16284748780-1ba0f9c33-519b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987
42708-002-142021-01-29C16284748780-1ba0f9c33-519b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-002CIPROFLOXACIN TABLET, FILM COATED [QPHARMA INC]7Legacy NDC20241123_7058e4d5-a308-46e0-915a-2a4f48689909.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-002-144270800021414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-002-14) 2018-05-090000-00-00YesNoCurrent