FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
51655-216
11-digit product format
516550216
Labeler code
51655
Product ID
51655-216_48d2ac12-e669-d797-e063-6394a90aaa7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077859
Marketing category
ANDA
Marketing start
2023-03-17
Marketing end
2027-02-28
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin

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
51655-216-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED205
51655-216-25Ciprofloxacin60 in 1 BOTTLE, PLASTICTABLET, FILM COATED605
51655-216-52Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305
51655-216-53Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED105
51655-216-84Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED145
51655-216-87Ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET, FILM COATED65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-216CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, 6 package rows20240127_f80ab01d-2533-1b4c-e053-6294a90a6e6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNf80ab01d-2533-1b4c-e053-6294a90a6e6a5
309309ciprofloxacin 500 MG Oral TabletSCDf80ab01d-2533-1b4c-e053-6294a90a6e6a5
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYf80ab01d-2533-1b4c-e053-6294a90a6e6a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-216-205165502162020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-20) 2023-06-282027-02-28NoNoHistorical
51655-216-255165502162560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-25) 2023-08-182027-02-28NoNoHistorical
51655-216-525165502165230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-52) 2024-01-102027-02-28NoNoHistorical
51655-216-535165502165310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-53) 2023-07-142027-02-28NoNoHistorical
51655-216-845165502168414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-84) 2023-06-082027-02-28NoNoHistorical
51655-216-87516550216876 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-87) 2023-03-172027-02-28NoNoHistorical