FDA.reportPublic FDA data

ciprofloxacin

Product NDC
0904-7243
11-digit product format
009047243
Labeler code
0904
Product ID
0904-7243_ec371e89-c5cc-4142-a3b6-38297f9b6dc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076639
Marketing category
ANDA
Marketing start
2022-08-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ciprofloxacin
Listing expiration
2027-12-31

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
0904-7243-61ciprofloxacin100 in 1 CARTONTABLET, FILM COATED1006
0904-7243-61ciprofloxacin1 in 1 BLISTER PACKTABLET, FILM COATED16
0904-7243-95ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7243CIPROFLOXACIN TABLET [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 3 package rows20250212_f818ed31-c746-4171-afdf-57a75434e5f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNf818ed31-c746-4171-afdf-57a75434e5f16
309309ciprofloxacin 500 MG Oral TabletSCDf818ed31-c746-4171-afdf-57a75434e5f16
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYf818ed31-c746-4171-afdf-57a75434e5f16
309309ciprofloxacin 500 MG Oral TabletPSN922e9f5c-cc59-4d9e-bf42-a4b900d077ed2
309309ciprofloxacin 500 MG Oral TabletSCD922e9f5c-cc59-4d9e-bf42-a4b900d077ed2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY922e9f5c-cc59-4d9e-bf42-a4b900d077ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7243-6100904724361100 BLISTER PACK in 1 CARTON (0904-7243-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2022-08-230000-00-00NoNoCurrent
0904-7243-950090472439520 TABLET, FILM COATED in 1 BOTTLE (0904-7243-95) 2022-08-230000-00-00NoNoCurrent