FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
50436-6041
11-digit product format
504366041
Labeler code
50436
Product ID
50436-6041_0a1819ad-cf70-405a-b3d0-263bc344996d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50436-6041-12021-01-29C16284748780-1ba0f9c33-2291-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987
50436-6041-22021-01-29C16284748780-1ba0f9c33-2291-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987
50436-6041-32021-01-29C16284748780-1ba0f9c33-2291-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987
50436-6041-92021-01-29C16284748780-1ba0f9c33-2291-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS . CIPROFLOXACIN tablet s , for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6041-1Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED208
50436-6041-2Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED148
50436-6041-3Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED108
50436-6041-9Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6041-1EA - Each50436-6041650a29b7-781e-4b7d-bf82-54a51bef3b5d12012-07-24
50436-6041-2EA - Each50436-60414ac6b738-28df-4658-9fae-4b3d7819850712012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6041CIPROFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]8Legacy NDC, 4 package rows20170816_084020fe-6571-4fb3-a13e-937615432fe8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN084020fe-6571-4fb3-a13e-937615432fe88
309309ciprofloxacin 500 MG Oral TabletSCD084020fe-6571-4fb3-a13e-937615432fe88
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY084020fe-6571-4fb3-a13e-937615432fe88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6041-15043660410120 in 1 BOTTLEHistorical
50436-6041-25043660410214 in 1 BOTTLEHistorical
50436-6041-35043660410310 in 1 BOTTLEHistorical
50436-6041-9504366041096 in 1 BOTTLEHistorical