FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
68071-3699
11-digit product format
680713699
Labeler code
68071
Product ID
68071-3699_4656418d-1f8e-b3bf-e063-6294a90a2401
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
250 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 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
68071-3699-1Ciprofloxacin10 in 1 BOTTLETABLET104
68071-3699-2Ciprofloxacin20 in 1 BOTTLETABLET204
68071-3699-3Ciprofloxacin30 in 1 BOTTLETABLET304
68071-3699-6Ciprofloxacin6 in 1 BOTTLETABLET64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3699CIPROFLOXACIN (CIPROFOLXACIN) TABLET [NUCARE PHARMACEUTICAL, INC.]2Current NDC, 4 package rows20241215_24760182-4be8-9f43-e063-6294a90a269e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN24760182-4be8-9f43-e063-6294a90a269e4
197511ciprofloxacin 250 MG Oral TabletSCD24760182-4be8-9f43-e063-6294a90a269e4
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY24760182-4be8-9f43-e063-6294a90a269e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3699-16807136990110 TABLET in 1 BOTTLE (68071-3699-1) 10 tablet2025-08-01NoNoCurrent
68071-3699-26807136990220 TABLET in 1 BOTTLE (68071-3699-2) 20 tablet2025-12-19NoNoCurrent
68071-3699-36807136990330 TABLET in 1 BOTTLE (68071-3699-3) 30 tablet2024-10-14NoNoCurrent
68071-3699-6680713699066 TABLET in 1 BOTTLE (68071-3699-6) 6 tablet2024-12-11NoNoCurrent