FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71335-2054
11-digit product format
713352054
Labeler code
71335
Product ID
71335-2054_901ae0da-246f-4d15-ad36-5b468edc2802
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208921
Marketing category
ANDA
Marketing start
2020-08-12
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
2027-12-31

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
71335-2054-0Ciprofloxacin7 in 1 BOTTLETABLET, COATED7103
71335-2054-1Ciprofloxacin14 in 1 BOTTLETABLET, COATED14103
71335-2054-2Ciprofloxacin30 in 1 BOTTLETABLET, COATED30103
71335-2054-3Ciprofloxacin20 in 1 BOTTLETABLET, COATED20103
71335-2054-4Ciprofloxacin60 in 1 BOTTLETABLET, COATED60103
71335-2054-5Ciprofloxacin6 in 1 BOTTLETABLET, COATED6103
71335-2054-6Ciprofloxacin10 in 1 BOTTLETABLET, COATED10103
71335-2054-7Ciprofloxacin28 in 1 BOTTLETABLET, COATED28103
71335-2054-8Ciprofloxacin100 in 1 BOTTLETABLET, COATED100103
71335-2054-9Ciprofloxacin40 in 1 BOTTLETABLET, COATED40103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2054CIPROFLOXACIN TABLET, COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240423_a05035e1-f941-4f7c-9321-91dd50ab149b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNa05035e1-f941-4f7c-9321-91dd50ab149b104
309309ciprofloxacin 500 MG Oral TabletSCDa05035e1-f941-4f7c-9321-91dd50ab149b104
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa05035e1-f941-4f7c-9321-91dd50ab149b104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2054-0713352054007 TABLET, COATED in 1 BOTTLE (71335-2054-0) 2024-04-030000-00-00NoNoCurrent
71335-2054-17133520540114 TABLET, COATED in 1 BOTTLE (71335-2054-1) 2023-03-200000-00-00NoNoCurrent
71335-2054-27133520540230 TABLET, COATED in 1 BOTTLE (71335-2054-2) 2022-03-210000-00-00NoNoCurrent
71335-2054-37133520540320 TABLET, COATED in 1 BOTTLE (71335-2054-3) 2023-03-170000-00-00NoNoCurrent
71335-2054-47133520540460 TABLET, COATED in 1 BOTTLE (71335-2054-4) 2023-06-010000-00-00NoNoCurrent
71335-2054-5713352054056 TABLET, COATED in 1 BOTTLE (71335-2054-5) 2023-08-310000-00-00NoNoCurrent
71335-2054-67133520540610 TABLET, COATED in 1 BOTTLE (71335-2054-6) 2023-06-210000-00-00NoNoCurrent
71335-2054-77133520540728 TABLET, COATED in 1 BOTTLE (71335-2054-7) 2023-03-280000-00-00NoNoCurrent
71335-2054-871335205408100 TABLET, COATED in 1 BOTTLE (71335-2054-8) 2024-04-030000-00-00NoNoCurrent
71335-2054-97133520540940 TABLET, COATED in 1 BOTTLE (71335-2054-9) 2024-04-030000-00-00NoNoCurrent