FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
50090-3791
11-digit product format
500903791
Labeler code
50090
Product ID
50090-3791_a8ca9c5b-77c7-492c-b145-f6b02260bcf9
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
2027-02-28
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
50090-3791-0Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED2018
50090-3791-1Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED1418
50090-3791-3Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED618
50090-3791-4Ciprofloxacin28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2818
50090-3791-5Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1018
50090-3791-7Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3018
50090-3791-8Ciprofloxacin1 in 1 BOTTLETABLET, FILM COATED118
50090-3791-9Ciprofloxacin1 in 1 BOTTLETABLET, FILM COATED118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3791-0EA - Each50090-37918780411f-47a9-4898-a028-244e06b70e8512021-10-08
50090-3791-1EA - Each50090-379172112d02-e5b4-4d90-911e-e9618f621aac12021-10-08
50090-3791-3EA - Each50090-3791dbe6cca1-6b22-4b2f-860c-d8516992b31212021-04-08
50090-3791-4EA - Each50090-3791d66f493a-ae78-4637-bb8b-afaec97e830112021-10-08
50090-3791-5EA - Each50090-3791bd3f0a3b-62be-4e8d-89d5-eeabe9fbe12312021-10-08
50090-3791-7EA - Each50090-3791b56379bb-afd2-4182-bcdd-291262e45f8712021-10-08
50090-3791-8EA - Each50090-3791f285d5ce-68b3-4cfd-b706-b389df7df78912024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3791CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 8 package rows20240215_9d83b127-ef13-4b2c-aa30-0f54937dc240.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN9d83b127-ef13-4b2c-aa30-0f54937dc24018
309309ciprofloxacin 500 MG Oral TabletSCD9d83b127-ef13-4b2c-aa30-0f54937dc24018
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY9d83b127-ef13-4b2c-aa30-0f54937dc24018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3791-05009037910020 TABLET, FILM COATED in 1 BOTTLE (50090-3791-0) 2018-11-080000-00-00NoNoCurrent
50090-3791-15009037910114 TABLET, FILM COATED in 1 BOTTLE (50090-3791-1) 2018-11-080000-00-00NoNoCurrent
50090-3791-3500903791036 TABLET, FILM COATED in 1 BOTTLE (50090-3791-3) 2018-11-080000-00-00NoNoCurrent
50090-3791-45009037910428 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3791-4) 2014-11-280000-00-00NoNoCurrent
50090-3791-55009037910510 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3791-5) 2014-11-280000-00-00NoNoCurrent
50090-3791-75009037910730 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3791-7) 2014-11-280000-00-00NoNoCurrent
50090-3791-8500903791081 in 1 BOTTLEHistorical
50090-3791-9500903791091 TABLET, FILM COATED in 1 BOTTLE (50090-3791-9) 2022-05-310000-00-00NoNoCurrent