Ciprofloxacin

Product NDC
11819-363
11-digit product format
118190363
Labeler code
11819
Product ID
11819-363_9f2ae085-ffaf-4287-93f0-0d480c2516fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HHS/Program Support Center/Supply Service Center
Application
ANDA075817
Marketing category
ANDA
Marketing start
2011-12-22
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
11819-363-002019-11-13C16284748780-197449f38-bd38-f6ea-e053-dbdaa90aa70388ee9c0e-aa2a-47ce-b649-25bfa6fc8a7b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11819-363-00Ciprofloxacin100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11819-363CIPROFLOXACIN TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1Legacy NDC, 1 package rows20120329_88ee9c0e-aa2a-47ce-b649-25bfa6fc8a7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN88ee9c0e-aa2a-47ce-b649-25bfa6fc8a7b1
309309ciprofloxacin 500 MG Oral TabletSCD88ee9c0e-aa2a-47ce-b649-25bfa6fc8a7b1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY88ee9c0e-aa2a-47ce-b649-25bfa6fc8a7b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11819-363-0011819036300100 in 1 BOTTLE, PLASTICHistorical