FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
63629-1010
11-digit product format
636291010
Labeler code
63629
Product ID
63629-1010_fc632cb9-a546-07a9-e053-6394a90a63b9
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
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

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-1010-12020-07-10C16284748780-19d75b9d0-37c9-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
63629-1010-22020-07-10C16284748780-19d75b9d0-37c9-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
63629-1010-32020-07-10C16284748780-19d75b9d0-37c9-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
63629-1010-42020-07-10C16284748780-19d75b9d0-37c9-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
63629-1010-52020-07-10C16284748780-19d75b9d0-37c9-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
63629-1010-62020-07-10C16284748780-19d75b9d0-37c9-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
63629-1010-72020-07-10C16284748780-19d75b9d0-37c9-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
63629-1010-82020-07-10C16284748780-19d75b9d0-37c9-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
63629-1010-12020-01-31C16284748780-19d75b9d0-37c9-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
63629-1010-22020-01-31C16284748780-19d75b9d0-37c9-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
63629-1010-32020-01-31C16284748780-19d75b9d0-37c9-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
63629-1010-42020-01-31C16284748780-19d75b9d0-37c9-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
63629-1010-52020-01-31C16284748780-19d75b9d0-37c9-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
63629-1010-62020-01-31C16284748780-19d75b9d0-37c9-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
63629-1010-72020-01-31C16284748780-19d75b9d0-37c9-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
63629-1010-82020-01-31C16284748780-19d75b9d0-37c9-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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1010-1Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED1008
63629-1010-2Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED208
63629-1010-3Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED308
63629-1010-4Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED148
63629-1010-5Ciprofloxacin500 in 1 BOTTLETABLET, FILM COATED5008
63629-1010-6Ciprofloxacin60 in 1 BOTTLETABLET, FILM COATED608
63629-1010-7Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED108
63629-1010-8Ciprofloxacin120 in 1 BOTTLETABLET, FILM COATED1208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1010-1EA - Each63629-10102dfced3d-162a-42d4-ae18-f735486fcad112020-08-06
63629-1010-2EA - Each63629-10107d8b681a-aa8e-4635-9e11-c77029d5b88512020-08-06
63629-1010-3EA - Each63629-101024fada3e-611b-406d-a668-98df34cdebe412020-08-06
63629-1010-4EA - Each63629-1010c41e90e9-6141-43bf-8152-2b97fe7966bf12020-08-06
63629-1010-5EA - Each63629-10101471e390-dc94-4563-abe3-6a40568fc04e12020-08-06
63629-1010-6EA - Each63629-1010f1ae8c3d-e992-470a-b3fb-f0eb1e7cdef712020-08-06
63629-1010-7EA - Each63629-1010253b519d-a863-4058-bd98-7329c1a6f12b12020-08-06
63629-1010-8EA - Each63629-1010ada4105a-0169-4864-bbb6-80b2aca02cb212020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1010CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 8 package rows20230525_8eef4f14-e7ef-41be-be57-7993b333e8a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN8eef4f14-e7ef-41be-be57-7993b333e8a98
309309ciprofloxacin 500 MG Oral TabletSCD8eef4f14-e7ef-41be-be57-7993b333e8a98
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY8eef4f14-e7ef-41be-be57-7993b333e8a98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1010-163629101001100 TABLET, FILM COATED in 1 BOTTLE (63629-1010-1) 2020-12-070000-00-00NoNoCurrent
63629-1010-26362910100220 TABLET, FILM COATED in 1 BOTTLE (63629-1010-2) 2020-09-230000-00-00NoNoCurrent
63629-1010-36362910100330 TABLET, FILM COATED in 1 BOTTLE (63629-1010-3) 2022-04-060000-00-00NoNoCurrent
63629-1010-46362910100414 TABLET, FILM COATED in 1 BOTTLE (63629-1010-4) 2021-10-250000-00-00NoNoCurrent
63629-1010-563629101005500 TABLET, FILM COATED in 1 BOTTLE (63629-1010-5) 2020-11-170000-00-00NoNoCurrent
63629-1010-66362910100660 TABLET, FILM COATED in 1 BOTTLE (63629-1010-6) 2022-04-060000-00-00NoNoCurrent
63629-1010-76362910100710 TABLET, FILM COATED in 1 BOTTLE (63629-1010-7) 2022-04-060000-00-00NoNoCurrent
63629-1010-863629101008120 TABLET, FILM COATED in 1 BOTTLE (63629-1010-8) 2022-04-060000-00-00NoNoCurrent