FDA.reportPublic FDA data

Ciprofloxacin HCL

Product NDC
80425-0192
11-digit product format
804250192
Labeler code
80425
Product ID
80425-0192_509c72a9-b580-72a3-e063-6394a90ad351
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA077859
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
2027-02-28
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 HCL

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
80425-0192-1Ciprofloxacin HCL20 in 1 BOTTLETABLET, FILM COATED205
80425-0192-2Ciprofloxacin HCL30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0192-1EA - Each80425-0192420e6287-e716-43fa-84d5-1f18fb3ec1f112023-03-13
80425-0192-2EA - Each80425-0192a76a8bc0-0731-475b-84dc-03d6d2b9f54112023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0192CIPROFLOXACIN HCL TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]4Current NDC, Legacy NDC, 2 package rows20250101_e237dd23-faf3-1765-e053-2a95a90ae62d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNe237dd23-faf3-1765-e053-2a95a90ae62d5
309309ciprofloxacin 500 MG Oral TabletSCDe237dd23-faf3-1765-e053-2a95a90ae62d5
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYe237dd23-faf3-1765-e053-2a95a90ae62d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0192-18042501920120 TABLET, FILM COATED in 1 BOTTLE (80425-0192-1) 2024-06-242027-02-28NoNoHistorical
80425-0192-28042501920230 TABLET, FILM COATED in 1 BOTTLE (80425-0192-2) 2024-06-242027-02-28NoNoHistorical