FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
63629-1009
11-digit product format
636291009
Labeler code
63629
Product ID
63629-1009_06625809-2b9c-4f2c-a3fc-73465200d473
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076126
Marketing category
ANDA
Marketing start
2009-10-10
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-1009-02020-07-10C16284748780-19d75b9d0-37c9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1009-12020-07-10C16284748780-19d75b9d0-37c9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1009-22020-07-10C16284748780-19d75b9d0-37c9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1009-32020-07-10C16284748780-19d75b9d0-37c9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1009-42020-07-10C16284748780-19d75b9d0-37c9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1009-52020-07-10C16284748780-19d75b9d0-37c9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1009-02020-01-31C16284748780-19d75b9d0-37c9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1009-12020-01-31C16284748780-19d75b9d0-37c9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1009-22020-01-31C16284748780-19d75b9d0-37c9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1009-32020-01-31C16284748780-19d75b9d0-37c9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1009-42020-01-31C16284748780-19d75b9d0-37c9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
63629-1009-52020-01-31C16284748780-19d75b9d0-37c9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1009-0636291009001000 TABLET, FILM COATED in 1 BOTTLE (63629-1009-0) 2009-10-100000-00-00NoNoCurrent
63629-1009-163629100901100 TABLET, FILM COATED in 1 BOTTLE (63629-1009-1) 2009-10-100000-00-00NoNoCurrent
63629-1009-26362910090220 TABLET, FILM COATED in 1 BOTTLE (63629-1009-2) 2009-10-100000-00-00NoNoCurrent
63629-1009-36362910090314 TABLET, FILM COATED in 1 BOTTLE (63629-1009-3) 2009-10-100000-00-00NoNoCurrent
63629-1009-46362910090440 TABLET, FILM COATED in 1 BOTTLE (63629-1009-4) 2009-10-100000-00-00NoNoCurrent
63629-1009-563629100905500 TABLET, FILM COATED in 1 BOTTLE (63629-1009-5) 2009-10-100000-00-00NoNoCurrent