FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
68071-3737
11-digit product format
680713737
Labeler code
68071
Product ID
68071-3737_36c17958-0221-9987-e063-6294a90ac4f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceutical, 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
68071-3737-2Ciprofloxacin2 in 1 BOTTLETABLET22
68071-3737-6Ciprofloxacin6 in 1 BOTTLETABLET62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3737CIPROFLOXACIN (CIPROFOLXACIN) TABLET [NUCARE PHARMACEUTICAL, INC.]1Current NDC, 2 package rows20241208_288ea7b2-ecf2-e8e0-e063-6294a90a306a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN288ea7b2-ecf2-e8e0-e063-6294a90a306a2
309309ciprofloxacin 500 MG Oral TabletSCD288ea7b2-ecf2-e8e0-e063-6294a90a306a2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY288ea7b2-ecf2-e8e0-e063-6294a90a306a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3737-2680713737022 TABLET in 1 BOTTLE (68071-3737-2) 2 tablet2024-12-05NoNoHistorical
68071-3737-6680713737066 TABLET in 1 BOTTLE (68071-3737-6) 6 tablet2025-06-04NoNoHistorical