FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
59651-976
11-digit product format
596510976
Labeler code
59651
Product ID
59651-976_9ec01bae-b28b-4585-8fae-3b3a07ab1bf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077859
Marketing category
ANDA
Marketing start
2025-03-27
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 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 HYDROCHLORIDE250 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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
59651-976-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED1003
59651-976-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED203
59651-976-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED303
59651-976-99Ciprofloxacin1000 in 1 BOTTLETABLET, FILM COATED10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-976CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2Current NDC, 4 package rows20250426_6a935846-3c97-4517-bc4e-2377f673285e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN6a935846-3c97-4517-bc4e-2377f673285e3
309309ciprofloxacin 500 MG Oral TabletPSN6a935846-3c97-4517-bc4e-2377f673285e3
197512ciprofloxacin 750 MG Oral TabletPSN6a935846-3c97-4517-bc4e-2377f673285e3
197511ciprofloxacin 250 MG Oral TabletSCD6a935846-3c97-4517-bc4e-2377f673285e3
309309ciprofloxacin 500 MG Oral TabletSCD6a935846-3c97-4517-bc4e-2377f673285e3
197512ciprofloxacin 750 MG Oral TabletSCD6a935846-3c97-4517-bc4e-2377f673285e3
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY6a935846-3c97-4517-bc4e-2377f673285e3
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY6a935846-3c97-4517-bc4e-2377f673285e3
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY6a935846-3c97-4517-bc4e-2377f673285e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-976-0159651097601100 TABLET, FILM COATED in 1 BOTTLE (59651-976-01) 2025-03-27NoNoCurrent
59651-976-205965109762020 TABLET, FILM COATED in 1 BOTTLE (59651-976-20) 2025-03-27NoNoCurrent
59651-976-305965109763030 TABLET, FILM COATED in 1 BOTTLE (59651-976-30) 2025-03-27NoNoCurrent
59651-976-39596510976393000 TABLET, FILM COATED in 1 BAG (59651-976-39)27-MAR-25Current
59651-976-99596510976991000 TABLET, FILM COATED in 1 BOTTLE (59651-976-99) 2025-03-27NoNoCurrent