Ciprofloxacin

Product NDC
67296-0580
11-digit product format
672960580
Labeler code
67296
Product ID
67296-0580_3392ce15-9b61-4777-8785-fa1d200ae385
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA076794
Marketing category
ANDA
Marketing start
2004-06-09
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
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0580-2Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED101
67296-0580-3Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED141
67296-0580-4Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED61
67296-0580-5Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
crospovidoneINACTIVE INGREDIENT68401960MKCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
polyvinyl alcoholINACTIVE INGREDIENT532B59J990CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0580CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1Legacy NDC, 4 package rows20110628_f03f5ae4-e698-417c-b033-b59249768fe2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNf03f5ae4-e698-417c-b033-b59249768fe21
309309ciprofloxacin 500 MG Oral TabletSCDf03f5ae4-e698-417c-b033-b59249768fe21
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYf03f5ae4-e698-417c-b033-b59249768fe21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0580-26729605800210 in 1 BOTTLEHistorical
67296-0580-36729605800314 in 1 BOTTLEHistorical
67296-0580-4672960580046 in 1 BOTTLEHistorical
67296-0580-56729605800520 in 1 BOTTLEHistorical