FDA.reportPublic FDA data

ciprofloxacin

Product NDC
51655-118
11-digit product format
516550118
Labeler code
51655
Product ID
51655-118_b8fa8de7-dac7-4d6c-a12c-96359843471f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA076639
Marketing category
ANDA
Marketing start
2014-06-01
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
51655-118-202026-01-29C16284748780-19d75b9d0-46f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-252026-01-29C16284748780-19d75b9d0-46f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-522026-01-29C16284748780-19d75b9d0-46f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-532026-01-29C16284748780-19d75b9d0-46f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-842026-01-29C16284748780-19d75b9d0-46f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-872026-01-29C16284748780-19d75b9d0-46f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-202023-07-03C16284748780-19d75b9d0-46f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-532023-07-03C16284748780-19d75b9d0-46f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-842023-07-03C16284748780-19d75b9d0-46f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-202020-01-31C16284748780-19d75b9d0-46f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-532020-01-31C16284748780-19d75b9d0-46f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-842020-01-31C16284748780-19d75b9d0-46f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-118-20ciprofloxacin20 in 1 BOTTLE, DISPENSINGTABLET206
51655-118-25ciprofloxacin60 in 1 BOTTLE, PLASTICTABLET606
51655-118-52ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET306
51655-118-53ciprofloxacin10 in 1 BOTTLE, DISPENSINGTABLET106
51655-118-84ciprofloxacin14 in 1 BOTTLE, DISPENSINGTABLET146
51655-118-87ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET66

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET [NORTHWIND PHARMACEUTICALS]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-118CIPROFLOXACIN TABLET [NORTHWIND PHARMACEUTICALS, LLC]6Legacy NDC, 6 package rows20240713_3f021061-55f3-4108-a386-0647b0c5f01a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN3f021061-55f3-4108-a386-0647b0c5f01a6
309309ciprofloxacin 500 MG Oral TabletSCD3f021061-55f3-4108-a386-0647b0c5f01a6
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY3f021061-55f3-4108-a386-0647b0c5f01a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51655-118-205165501182020 in 1 BOTTLE, DISPENSINGHistorical
51655-118-255165501182560 in 1 BOTTLE, PLASTICHistorical
51655-118-525165501185230 in 1 BOTTLE, PLASTICHistorical
51655-118-535165501185310 in 1 BOTTLE, DISPENSINGHistorical
51655-118-845165501188414 in 1 BOTTLE, DISPENSINGHistorical
51655-118-87516550118876 in 1 BOTTLE, PLASTICHistorical