Ciprofloxacin

Product NDC
83008-078
11-digit product format
830080078
Labeler code
83008
Product ID
83008-078_d6e43461-8fb9-44e4-998b-b501bbabf58b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA208921
Marketing category
ANDA
Marketing start
2024-08-21
Marketing end
2026-08-31
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin

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
83008-078-20Ciprofloxacin20 in 1 BOTTLETABLET204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83008-078CIPROFLOXACIN (CIPROFOLXACIN) TABLET [QUALITY CARE PRODUCTS, LLC]4Current NDC, 1 package rows20241222_a0eda476-1625-4e9e-bb76-4f1cf05562f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNa0eda476-1625-4e9e-bb76-4f1cf05562f04
309309ciprofloxacin 500 MG Oral TabletSCDa0eda476-1625-4e9e-bb76-4f1cf05562f04
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa0eda476-1625-4e9e-bb76-4f1cf05562f04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83008-078-208300800782020 TABLET in 1 BOTTLE (83008-078-20) 20 tablet2024-08-212026-08-31NoNoHistorical