FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
82804-256
11-digit product format
828040256
Labeler code
82804
Product ID
82804-256_6635fc8b-5662-4024-b813-b6e0190f5b17
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
250 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 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
82804-256-06Ciprofloxacin6 in 1 BOTTLETABLET62
82804-256-14Ciprofloxacin14 in 1 BOTTLETABLET142
82804-256-20Ciprofloxacin20 in 1 BOTTLETABLET202

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN9f00ae9d-8707-4275-9eba-2ed72db8aea12
197511ciprofloxacin 250 MG Oral TabletSCD9f00ae9d-8707-4275-9eba-2ed72db8aea12
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY9f00ae9d-8707-4275-9eba-2ed72db8aea12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-256-06828040256066 TABLET in 1 BOTTLE (82804-256-06) 6 tablet2025-12-18NoNoCurrent
82804-256-148280402561414 TABLET in 1 BOTTLE (82804-256-14) 14 tablet2026-04-13NoNoCurrent
82804-256-208280402562020 TABLET in 1 BOTTLE (82804-256-20) 20 tablet2025-12-18NoNoCurrent