FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
61442-224
11-digit product format
614420224
Labeler code
61442
Product ID
61442-224_2d6a2060-1f59-696d-e063-6394a90a2796
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA076126
Marketing category
ANDA
Marketing start
2009-10-10
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
61442-224-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED10016
61442-224-04Ciprofloxacin400 in 1 BOTTLETABLET, FILM COATED40016
61442-224-50Ciprofloxacin50 in 1 BOTTLETABLET, FILM COATED5016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-224-50EA - Each61442-22463cb1647-a4f8-499e-be34-d93d668daecd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2CIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TCIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7
TRIACETININACTIVE INGREDIENTXHX3C3X673CIPROFLOXACIN TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-224CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]16Current NDC, Legacy NDC, 3 package rows20250207_37527eca-115e-4582-88cd-bba851ac6069.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN37527eca-115e-4582-88cd-bba851ac606916
309309ciprofloxacin 500 MG Oral TabletPSN37527eca-115e-4582-88cd-bba851ac606916
197512ciprofloxacin 750 MG Oral TabletPSN37527eca-115e-4582-88cd-bba851ac606916
197511ciprofloxacin 250 MG Oral TabletSCD37527eca-115e-4582-88cd-bba851ac606916
309309ciprofloxacin 500 MG Oral TabletSCD37527eca-115e-4582-88cd-bba851ac606916
197512ciprofloxacin 750 MG Oral TabletSCD37527eca-115e-4582-88cd-bba851ac606916
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY37527eca-115e-4582-88cd-bba851ac606916
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY37527eca-115e-4582-88cd-bba851ac606916
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY37527eca-115e-4582-88cd-bba851ac606916
197511ciprofloxacin 250 MG Oral TabletPSN1b54c195-71ba-2523-e063-6294a90ada734
197512ciprofloxacin 750 MG Oral TabletPSN1b54c195-71ba-2523-e063-6294a90ada734
197511ciprofloxacin 250 MG Oral TabletSCD1b54c195-71ba-2523-e063-6294a90ada734
197512ciprofloxacin 750 MG Oral TabletSCD1b54c195-71ba-2523-e063-6294a90ada734
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY1b54c195-71ba-2523-e063-6294a90ada734
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY1b54c195-71ba-2523-e063-6294a90ada734

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61442-224-0161442022401100 TABLET, FILM COATED in 1 BOTTLE (61442-224-01) 2009-10-100000-00-00NoNoCurrent
61442-224-0461442022404400 TABLET, FILM COATED in 1 BOTTLE (61442-224-04) 2009-10-100000-00-00NoNoCurrent
61442-224-506144202245050 TABLET, FILM COATED in 1 BOTTLE (61442-224-50) 2009-10-100000-00-00NoNoCurrent