FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
51655-490
11-digit product format
516550490
Labeler code
51655
Product ID
51655-490_490f7c8c-c3f7-bc3e-e063-6294a90af23e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA208921
Marketing category
ANDA
Marketing start
2023-01-05
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 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 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
51655-490-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, COATED202
51655-490-52Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, COATED302
51655-490-53Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET, COATED102
51655-490-84Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, COATED142
51655-490-87Ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET, COATED62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-490CIPROFLOXACIN TABLET, COATED [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 5 package rows20230318_f6debb60-d885-230b-e053-6394a90ad73a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNf6debb60-d885-230b-e053-6394a90ad73a2
309309ciprofloxacin 500 MG Oral TabletSCDf6debb60-d885-230b-e053-6394a90ad73a2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYf6debb60-d885-230b-e053-6394a90ad73a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-490-205165504902020 TABLET, COATED in 1 BOTTLE, PLASTIC (51655-490-20) 2023-02-03NoNoCurrent
51655-490-525165504905230 TABLET, COATED in 1 BOTTLE, PLASTIC (51655-490-52) 2023-01-05NoNoCurrent
51655-490-535165504905310 TABLET, COATED in 1 BOTTLE, PLASTIC (51655-490-53) 2023-02-03NoNoCurrent
51655-490-845165504908414 TABLET, COATED in 1 BOTTLE, PLASTIC (51655-490-84) 2023-01-20NoNoCurrent
51655-490-87516550490876 TABLET, COATED in 1 BOTTLE, PLASTIC (51655-490-87) 2023-01-05NoNoCurrent