FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
68071-3610
11-digit product format
680713610
Labeler code
68071
Product ID
68071-3610_4511d473-8ed3-489c-e063-6294a90a7919
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
68071-3610-1Ciprofloxacin10 in 1 BOTTLETABLET105
68071-3610-2Ciprofloxacin20 in 1 BOTTLETABLET205
68071-3610-4Ciprofloxacin14 in 1 BOTTLETABLET145
68071-3610-6Ciprofloxacin6 in 1 BOTTLETABLET65
68071-3610-8Ciprofloxacin28 in 1 BOTTLETABLET285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3610CIPROFLOXACIN (CIPROFOLXACIN) TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 5 package rows20240724_1b189dba-0493-c9b4-e063-6294a90a7d1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN1b189dba-0493-c9b4-e063-6294a90a7d1e5
309309ciprofloxacin 500 MG Oral TabletSCD1b189dba-0493-c9b4-e063-6294a90a7d1e5
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY1b189dba-0493-c9b4-e063-6294a90a7d1e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3610-16807136100110 TABLET in 1 BOTTLE (68071-3610-1) 10 tablet2024-06-17NoNoHistorical
68071-3610-26807136100220 TABLET in 1 BOTTLE (68071-3610-2) 20 tablet2024-06-17NoNoHistorical
68071-3610-46807136100414 TABLET in 1 BOTTLE (68071-3610-4) 14 tablet2024-06-17NoNoHistorical
68071-3610-6680713610066 TABLET in 1 BOTTLE (68071-3610-6) 6 tablet2025-08-05NoNoHistorical
68071-3610-86807136100828 TABLET in 1 BOTTLE (68071-3610-8) 28 tablet2025-12-03NoNoHistorical