Ciprofloxacin

Product NDC
11819-323
11-digit product format
118190323
Labeler code
11819
Product ID
11819-323_dc9e0bf6-012f-47c2-8b54-a4a7a2530ed2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HHS/Program Support Center/Supply Service Center
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11819-323-302019-11-13C16284748780-197449f38-d0a9-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11819-323-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
crospovidoneINACTIVE INGREDIENT68401960MKCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
polyvinyl alcoholINACTIVE INGREDIENT532B59J990CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
talcINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 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
11819-323CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1Legacy NDC, 1 package rows20120302_42c00a53-66db-4c8b-b5db-ccb9d02e5344.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN42c00a53-66db-4c8b-b5db-ccb9d02e53441
309309ciprofloxacin 500 MG Oral TabletSCD42c00a53-66db-4c8b-b5db-ccb9d02e53441
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY42c00a53-66db-4c8b-b5db-ccb9d02e53441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11819-323-301181903233030 in 1 BOTTLEHistorical