CIPROFLOXACIN HYDROCHLORIDE

Product NDC
67296-0543
11-digit product format
672960543
Labeler code
67296
Product ID
67296-0543_6150bd37-2019-48fa-8dde-5b361f61cedc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin hydrochloride tablet
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA076089
Marketing category
ANDA
Marketing start
2011-04-04
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
67296-0543-2CIPROFLOXACIN HYDROCHLORIDE10 in 1 BOTTLETABLET102
67296-0543-3CIPROFLOXACIN HYDROCHLORIDE14 in 1 BOTTLETABLET142
67296-0543-4CIPROFLOXACIN HYDROCHLORIDE6 in 1 BOTTLETABLET62
67296-0543-5CIPROFLOXACIN HYDROCHLORIDE20 in 1 BOTTLETABLET202

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0543CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE TABLET) TABLET [REDPHARM DRUG INC.]2Legacy NDC, 4 package rows20110627_e797d0eb-eabb-432a-8053-64eff753f1b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNe797d0eb-eabb-432a-8053-64eff753f1b02
309309ciprofloxacin 500 MG Oral TabletSCDe797d0eb-eabb-432a-8053-64eff753f1b02
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYe797d0eb-eabb-432a-8053-64eff753f1b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0543-26729605430210 in 1 BOTTLEHistorical
67296-0543-36729605430314 in 1 BOTTLEHistorical
67296-0543-4672960543046 in 1 BOTTLEHistorical
67296-0543-56729605430520 in 1 BOTTLEHistorical