FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
72162-2425
11-digit product format
721622425
Labeler code
72162
Product ID
72162-2425_54fb9efb-e34f-4d04-922b-c80eeb1c1200
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
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
72162-2425-1Ciprofloxacin100 in 1 BOTTLETABLET100100
72162-2425-2Ciprofloxacin20 in 1 BOTTLETABLET20100
72162-2425-3Ciprofloxacin30 in 1 BOTTLETABLET30100
72162-2425-4Ciprofloxacin28 in 1 BOTTLETABLET28100
72162-2425-5Ciprofloxacin500 in 1 BOTTLETABLET500100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2425CIPROFLOXACIN (CIPROFOLXACIN) TABLET [BRYANT RANCH PREPACK]100Current NDC, 5 package rows20241114_ab16bacd-f73f-462e-82b2-b0abb1c49cec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNab16bacd-f73f-462e-82b2-b0abb1c49cec100
309309ciprofloxacin 500 MG Oral TabletSCDab16bacd-f73f-462e-82b2-b0abb1c49cec100
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYab16bacd-f73f-462e-82b2-b0abb1c49cec100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2425-172162242501100 TABLET in 1 BOTTLE (72162-2425-1) 100 tablet2024-11-12NoNoCurrent
72162-2425-27216224250220 TABLET in 1 BOTTLE (72162-2425-2) 20 tablet2024-11-12NoNoCurrent
72162-2425-37216224250330 TABLET in 1 BOTTLE (72162-2425-3) 30 tablet2024-11-12NoNoCurrent
72162-2425-47216224250428 TABLET in 1 BOTTLE (72162-2425-4) 28 tablet2024-11-12NoNoCurrent
72162-2425-572162242505500 TABLET in 1 BOTTLE (72162-2425-5) 500 tablet2024-11-12NoNoCurrent