FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71335-2502
11-digit product format
713352502
Labeler code
71335
Product ID
71335-2502_64c0aefd-0ce3-4ad3-b39c-8bcb910bd02e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208921
Marketing category
ANDA
Marketing start
2023-10-01
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 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 HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197511

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
71335-2502-0Ciprofloxacin7 in 1 BOTTLETABLET72
71335-2502-1Ciprofloxacin20 in 1 BOTTLETABLET202
71335-2502-2Ciprofloxacin10 in 1 BOTTLETABLET102
71335-2502-3Ciprofloxacin14 in 1 BOTTLETABLET142
71335-2502-4Ciprofloxacin6 in 1 BOTTLETABLET62
71335-2502-5Ciprofloxacin30 in 1 BOTTLETABLET302
71335-2502-6Ciprofloxacin60 in 1 BOTTLETABLET602
71335-2502-7Ciprofloxacin12 in 1 BOTTLETABLET122
71335-2502-8Ciprofloxacin40 in 1 BOTTLETABLET402
71335-2502-9Ciprofloxacin90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2502CIPROFLOXACIN (CIPROFOLXACIN) TABLET [BRYANT RANCH PREPACK]2Current NDC, 10 package rows20250227_c9108da9-c271-4e9e-a035-8dd3019e8cf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNc9108da9-c271-4e9e-a035-8dd3019e8cf32
197511ciprofloxacin 250 MG Oral TabletSCDc9108da9-c271-4e9e-a035-8dd3019e8cf32
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYc9108da9-c271-4e9e-a035-8dd3019e8cf32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2502-0713352502007 TABLET in 1 BOTTLE (71335-2502-0) 7 tablet2024-09-23NoNoHistorical
71335-2502-17133525020120 TABLET in 1 BOTTLE (71335-2502-1) 20 tablet2024-09-23NoNoHistorical
71335-2502-27133525020210 TABLET in 1 BOTTLE (71335-2502-2) 10 tablet2024-09-23NoNoHistorical
71335-2502-37133525020314 TABLET in 1 BOTTLE (71335-2502-3) 14 tablet2024-09-23NoNoHistorical
71335-2502-4713352502046 TABLET in 1 BOTTLE (71335-2502-4) 6 tablet2024-09-23NoNoHistorical
71335-2502-57133525020530 TABLET in 1 BOTTLE (71335-2502-5) 30 tablet2024-09-23NoNoHistorical
71335-2502-67133525020660 TABLET in 1 BOTTLE (71335-2502-6) 60 tablet2024-09-23NoNoHistorical
71335-2502-77133525020712 TABLET in 1 BOTTLE (71335-2502-7) 12 tablet2024-09-23NoNoHistorical
71335-2502-87133525020840 TABLET in 1 BOTTLE (71335-2502-8) 40 tablet2024-09-23NoNoHistorical
71335-2502-97133525020990 TABLET in 1 BOTTLE (71335-2502-9) 90 tablet2024-09-23NoNoHistorical