FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
42708-088
11-digit product format
427080088
Labeler code
42708
Product ID
42708-088_4651ca6a-1e32-ac25-e063-6294a90a02e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma Inc
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42708-088-142021-03-12C16284748780-1ba0f9c33-2eb0-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
42708-088-142021-01-29C16284748780-1ba0f9c33-2eb0-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-088-14Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-088CIPROFLOXACIN TABLET, FILM COATED [QPHARMA INC]10Current NDC, Legacy NDC, 1 package rows20241123_4d5afeff-3917-43e1-9d12-d70ccab00dcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN4d5afeff-3917-43e1-9d12-d70ccab00dcc11
309309ciprofloxacin 500 MG Oral TabletSCD4d5afeff-3917-43e1-9d12-d70ccab00dcc11
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY4d5afeff-3917-43e1-9d12-d70ccab00dcc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-088-144270800881414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-088-14) 2019-01-112027-02-28YesNoCurrent