FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
50090-2146
11-digit product format
500902146
Labeler code
50090
Product ID
50090-2146_8c5d8ad7-6045-451e-8b78-4c06c5e7fc96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077859
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
2027-01-31
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 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 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
50090-2146-0Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED622
50090-2146-1Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED1422
50090-2146-2Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED1022
50090-2146-3Ciprofloxacin3 in 1 BOTTLETABLET, FILM COATED322

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2146-0EA - Each50090-2146b7bd79f9-1670-48b3-844c-24c56d8153ff12021-09-07
50090-2146-1EA - Each50090-2146ddfec0fd-c6cd-4530-b220-30630eb353e212021-09-07
50090-2146-2EA - Each50090-214648ce1537-05d8-48fe-89c5-5de7b530b09e12021-09-07
50090-2146-3EA - Each50090-21468181ab0b-2db6-408a-a9b1-42a927f4c21f12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2146CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 4 package rows20241003_4dd69fb7-802a-4278-a730-c722a3ca3521.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN4dd69fb7-802a-4278-a730-c722a3ca352122
197511ciprofloxacin 250 MG Oral TabletSCD4dd69fb7-802a-4278-a730-c722a3ca352122
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY4dd69fb7-802a-4278-a730-c722a3ca352122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2146-0500902146006 TABLET, FILM COATED in 1 BOTTLE (50090-2146-0) 2015-10-200000-00-00NoNoCurrent
50090-2146-15009021460114 TABLET, FILM COATED in 1 BOTTLE (50090-2146-1) 2015-10-200000-00-00NoNoCurrent
50090-2146-25009021460210 TABLET, FILM COATED in 1 BOTTLE (50090-2146-2) 2015-10-200000-00-00NoNoCurrent
50090-2146-3500902146033 TABLET, FILM COATED in 1 BOTTLE (50090-2146-3) 2019-08-130000-00-00NoNoCurrent