FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71335-0836
11-digit product format
713350836
Labeler code
71335
Product ID
71335-0836_8a77321c-61a9-4a3a-aecf-73c3e706c122
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076126
Marketing category
ANDA
Marketing start
2009-10-10
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0836-0Ciprofloxacin7 in 1 BOTTLETABLET, FILM COATED76
71335-0836-1Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED206
71335-0836-2Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED106
71335-0836-3Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED146
71335-0836-4Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED66
71335-0836-5Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED306
71335-0836-6Ciprofloxacin60 in 1 BOTTLETABLET, FILM COATED606
71335-0836-7Ciprofloxacin12 in 1 BOTTLETABLET, FILM COATED126
71335-0836-8Ciprofloxacin40 in 1 BOTTLETABLET, FILM COATED406
71335-0836-9Ciprofloxacin90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0836-1EA - Each71335-0836ca549799-f2f7-4f90-bc75-fb1c7da6345112020-09-14
71335-0836-2EA - Each71335-08368bdee067-aef9-464a-a32f-fd849ddd0ebb12020-09-14
71335-0836-3EA - Each71335-083677ba95cd-a0c6-438d-ba8f-5fe23905348512018-10-11
71335-0836-4EA - Each71335-0836758a8270-8403-4167-b031-7d5aa7aa491a12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0836CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]6Legacy NDC, 10 package rows20241027_b283d662-9be1-49c7-be03-cb21055314c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNb283d662-9be1-49c7-be03-cb21055314c16
309309ciprofloxacin 500 MG Oral TabletPSNb283d662-9be1-49c7-be03-cb21055314c16
197511ciprofloxacin 250 MG Oral TabletSCDb283d662-9be1-49c7-be03-cb21055314c16
309309ciprofloxacin 500 MG Oral TabletSCDb283d662-9be1-49c7-be03-cb21055314c16
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYb283d662-9be1-49c7-be03-cb21055314c16
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYb283d662-9be1-49c7-be03-cb21055314c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0836-0713350836007 TABLET, FILM COATED in 1 BOTTLE (71335-0836-0) 2012-09-050000-00-00NoNoCurrent
71335-0836-17133508360120 TABLET, FILM COATED in 1 BOTTLE (71335-0836-1) 2012-09-050000-00-00NoNoCurrent
71335-0836-27133508360210 TABLET, FILM COATED in 1 BOTTLE (71335-0836-2) 2012-09-050000-00-00NoNoCurrent
71335-0836-37133508360314 TABLET, FILM COATED in 1 BOTTLE (71335-0836-3) 2012-09-050000-00-00NoNoCurrent
71335-0836-4713350836046 TABLET, FILM COATED in 1 BOTTLE (71335-0836-4) 2012-09-050000-00-00NoNoCurrent
71335-0836-57133508360530 TABLET, FILM COATED in 1 BOTTLE (71335-0836-5) 2012-09-050000-00-00NoNoCurrent
71335-0836-67133508360660 TABLET, FILM COATED in 1 BOTTLE (71335-0836-6) 2012-09-050000-00-00NoNoCurrent
71335-0836-77133508360712 TABLET, FILM COATED in 1 BOTTLE (71335-0836-7) 2012-09-050000-00-00NoNoCurrent
71335-0836-87133508360840 TABLET, FILM COATED in 1 BOTTLE (71335-0836-8) 2012-09-050000-00-00NoNoCurrent
71335-0836-97133508360990 TABLET, FILM COATED in 1 BOTTLE (71335-0836-9) 2012-09-050000-00-00NoNoCurrent