FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71335-2046
11-digit product format
713352046
Labeler code
71335
Product ID
71335-2046_0b577d32-713b-4ad8-b6f0-d54f886c38c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077859
Marketing category
ANDA
Marketing start
2007-04-26
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui309309

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
71335-2046-0Ciprofloxacin7 in 1 BOTTLETABLET, FILM COATED7104
71335-2046-1Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED14104
71335-2046-2Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED30104
71335-2046-3Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED20104
71335-2046-4Ciprofloxacin60 in 1 BOTTLETABLET, FILM COATED60104
71335-2046-5Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED6104
71335-2046-6Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED10104
71335-2046-7Ciprofloxacin28 in 1 BOTTLETABLET, FILM COATED28104
71335-2046-8Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED100104
71335-2046-9Ciprofloxacin40 in 1 BOTTLETABLET, FILM COATED40104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2046-3EA - Each71335-204680cf14ba-4425-4f7c-8e40-ef14b947769c12023-06-06
71335-2046-8EA - Each71335-2046e7a70e7e-5c54-4db7-b56f-152efc42366312024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2046CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240423_ac87e3c7-1e51-4dd1-8b75-dec6536810e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNac87e3c7-1e51-4dd1-8b75-dec6536810e3104
309309ciprofloxacin 500 MG Oral TabletSCDac87e3c7-1e51-4dd1-8b75-dec6536810e3104
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYac87e3c7-1e51-4dd1-8b75-dec6536810e3104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2046-0713352046007 TABLET, FILM COATED in 1 BOTTLE (71335-2046-0) 2024-04-030000-00-00NoNoCurrent
71335-2046-17133520460114 TABLET, FILM COATED in 1 BOTTLE (71335-2046-1) 2022-02-160000-00-00NoNoCurrent
71335-2046-27133520460230 TABLET, FILM COATED in 1 BOTTLE (71335-2046-2) 2022-03-010000-00-00NoNoCurrent
71335-2046-37133520460320 TABLET, FILM COATED in 1 BOTTLE (71335-2046-3) 2022-02-160000-00-00NoNoCurrent
71335-2046-47133520460460 TABLET, FILM COATED in 1 BOTTLE (71335-2046-4) 2022-06-200000-00-00NoNoCurrent
71335-2046-5713352046056 TABLET, FILM COATED in 1 BOTTLE (71335-2046-5) 2022-05-170000-00-00NoNoCurrent
71335-2046-67133520460610 TABLET, FILM COATED in 1 BOTTLE (71335-2046-6) 2022-02-150000-00-00NoNoCurrent
71335-2046-77133520460728 TABLET, FILM COATED in 1 BOTTLE (71335-2046-7) 2022-03-070000-00-00NoNoCurrent
71335-2046-871335204608100 TABLET, FILM COATED in 1 BOTTLE (71335-2046-8) 2022-11-290000-00-00NoNoCurrent
71335-2046-97133520460940 TABLET, FILM COATED in 1 BOTTLE (71335-2046-9) 2024-04-030000-00-00NoNoCurrent