Ciprofloxacin Hydrochloride

Product NDC
66116-508
11-digit product format
661160508
Labeler code
66116
Product ID
66116-508_6fecbc15-915c-4434-b9e3-cfc1aa33a1ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA076089
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66116-508-102019-11-27C16284748780-19855d018-ee16-cd31-e053-dbdaa90ab51aCIPROFLOXACIN TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-508-10Ciprofloxacin Hydrochloride10 in 1 BOTTLETABLET101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-508CIPROFLOXACIN HYDROCHLORIDE TABLET [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130820_6fecbc15-915c-4434-b9e3-cfc1aa33a1ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN6fecbc15-915c-4434-b9e3-cfc1aa33a1ba1
309309ciprofloxacin 500 MG Oral TabletSCD6fecbc15-915c-4434-b9e3-cfc1aa33a1ba1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY6fecbc15-915c-4434-b9e3-cfc1aa33a1ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-508-106611605081010 in 1 BOTTLEHistorical