FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
85766-100
11-digit product format
857660100
Labeler code
85766
Product ID
85766-100_5031c86c-38c0-9587-e063-6294a90afff2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
Sportpharm LLC
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
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 HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197511, 309309

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
85766-100-01Ciprofloxacin100 in 1 BOTTLETABLET1002
85766-100-10Ciprofloxacin10 in 1 BOTTLETABLET102
85766-100-20Ciprofloxacin20 in 1 BOTTLETABLET202
85766-100-30Ciprofloxacin30 in 1 BOTTLETABLET302
85766-100-60Ciprofloxacin60 in 1 BOTTLETABLET602
85766-100-90Ciprofloxacin90 in 1 BOTTLETABLET902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNd38b5160-4c1c-41d9-8f13-f9f877778f9c2
309309ciprofloxacin 500 MG Oral TabletPSNd38b5160-4c1c-41d9-8f13-f9f877778f9c2
197511ciprofloxacin 250 MG Oral TabletSCDd38b5160-4c1c-41d9-8f13-f9f877778f9c2
309309ciprofloxacin 500 MG Oral TabletSCDd38b5160-4c1c-41d9-8f13-f9f877778f9c2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd38b5160-4c1c-41d9-8f13-f9f877778f9c2
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYd38b5160-4c1c-41d9-8f13-f9f877778f9c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-100-0185766010001100 TABLET in 1 BOTTLE (85766-100-01) 100 tablet2025-10-10NoNoHistorical
85766-100-108576601001010 TABLET in 1 BOTTLE (85766-100-10) 10 tablet2025-10-10NoNoHistorical
85766-100-208576601002020 TABLET in 1 BOTTLE (85766-100-20) 20 tablet2025-10-10NoNoHistorical
85766-100-308576601003030 TABLET in 1 BOTTLE (85766-100-30) 30 tablet2025-10-10NoNoHistorical
85766-100-608576601006060 TABLET in 1 BOTTLE (85766-100-60) 60 tablet2025-10-10NoNoHistorical
85766-100-908576601009090 TABLET in 1 BOTTLE (85766-100-90) 90 tablet2025-10-10NoNoHistorical