Ciprofloxacin

Product NDC
69238-2434
11-digit product format
692382434
Labeler code
69238
Product ID
69238-2434_d44c6eb1-e419-4bee-977a-b1b46444595f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA075939
Marketing category
ANDA
Marketing start
2024-02-29
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
750 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 HYDROCHLORIDE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197511, 197512, 309309

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
69238-2434-1Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED1003
69238-2434-5Ciprofloxacin50 in 1 BOTTLETABLET, FILM COATED503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2434CIPROFLOXACIN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]3Current NDC, 2 package rows20241210_b996e81b-36ec-4ad7-a7c4-bc6700a06648.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNb996e81b-36ec-4ad7-a7c4-bc6700a066483
309309ciprofloxacin 500 MG Oral TabletPSNb996e81b-36ec-4ad7-a7c4-bc6700a066483
197512ciprofloxacin 750 MG Oral TabletPSNb996e81b-36ec-4ad7-a7c4-bc6700a066483
197511ciprofloxacin 250 MG Oral TabletSCDb996e81b-36ec-4ad7-a7c4-bc6700a066483
309309ciprofloxacin 500 MG Oral TabletSCDb996e81b-36ec-4ad7-a7c4-bc6700a066483
197512ciprofloxacin 750 MG Oral TabletSCDb996e81b-36ec-4ad7-a7c4-bc6700a066483
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYb996e81b-36ec-4ad7-a7c4-bc6700a066483
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSYb996e81b-36ec-4ad7-a7c4-bc6700a066483
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYb996e81b-36ec-4ad7-a7c4-bc6700a066483

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69238-2434-169238243401100 TABLET, FILM COATED in 1 BOTTLE (69238-2434-1) 2024-02-29NoNoCurrent
69238-2434-56923824340550 TABLET, FILM COATED in 1 BOTTLE (69238-2434-5) 2024-02-29NoNoCurrent