FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
51655-086
11-digit product format
516550086
Labeler code
51655
Product ID
51655-086_4b1b7f42-1489-a2fe-e063-6394a90af32b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076558
Marketing category
ANDA
Marketing start
2023-03-01
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

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
51655-086-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2028
51655-086-84Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1428

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-086CIPROFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20230706_f67d727f-b9ca-aec0-e053-2995a90aab69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNf67d727f-b9ca-aec0-e053-2995a90aab6928
197511ciprofloxacin 250 MG Oral TabletSCDf67d727f-b9ca-aec0-e053-2995a90aab6928
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYf67d727f-b9ca-aec0-e053-2995a90aab6928

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-086-205165500862020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-086-20) 2023-06-22NoNoHistorical
51655-086-845165500868414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-086-84) 2023-03-01NoNoHistorical