FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
82804-130
11-digit product format
828040130
Labeler code
82804
Product ID
82804-130_ee0e72c6-18ff-4219-b067-26578a27ce79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
82804-130-06Ciprofloxacin6 in 1 BOTTLETABLET62
82804-130-10Ciprofloxacin10 in 1 BOTTLETABLET102
82804-130-14Ciprofloxacin14 in 1 BOTTLETABLET142
82804-130-20Ciprofloxacin20 in 1 BOTTLETABLET202
82804-130-30Ciprofloxacin30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-130CIPROFLOXACIN (CIPROFOLXACIN) TABLET [PROFICIENT RX LP]2Current NDC, 5 package rows20250504_0ce2221d-940f-4c07-ba2e-fccb491f6b9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN0ce2221d-940f-4c07-ba2e-fccb491f6b9b2
309309ciprofloxacin 500 MG Oral TabletSCD0ce2221d-940f-4c07-ba2e-fccb491f6b9b2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY0ce2221d-940f-4c07-ba2e-fccb491f6b9b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-130-06828040130066 TABLET in 1 BOTTLE (82804-130-06) 6 tablet2024-09-05NoNoCurrent
82804-130-108280401301010 TABLET in 1 BOTTLE (82804-130-10) 10 tablet2024-09-05NoNoCurrent
82804-130-148280401301414 TABLET in 1 BOTTLE (82804-130-14) 14 tablet2024-09-05NoNoCurrent
82804-130-208280401302020 TABLET in 1 BOTTLE (82804-130-20) 20 tablet2024-09-05NoNoCurrent
82804-130-308280401303030 TABLET in 1 BOTTLE (82804-130-30) 30 tablet2025-04-28NoNoCurrent