ciprofloxacin hydrochloride

Product NDC
53401-005
11-digit product format
534010005
Labeler code
53401
Product ID
53401-005_9770c576-1eb6-41ab-ab4d-886121391ca6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Testpak Holding Company
Application
ANDA076794
Marketing category
ANDA
Marketing start
2009-12-03
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
53401-005-202019-10-21C16284748780-1956f9ecf-d78e-621f-e053-dbdaa90a74adCIPROFLOXACIN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53401-005-20ciprofloxacin hydrochloride20 in 1 BOTTLETABLET, COATED201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN HYDROCHLORIDE TABLET, COATED [TESTPAK HOLDING COMPANY]1
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN HYDROCHLORIDE TABLET, COATED [TESTPAK HOLDING COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53401-005CIPROFLOXACIN HYDROCHLORIDE TABLET, COATED [TESTPAK HOLDING COMPANY]1Legacy NDC, 1 package rows20100304_8c353bf4-f26b-4ab8-9694-aa9f10dfe965.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN8c353bf4-f26b-4ab8-9694-aa9f10dfe9651
309309ciprofloxacin 500 MG Oral TabletSCD8c353bf4-f26b-4ab8-9694-aa9f10dfe9651
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY8c353bf4-f26b-4ab8-9694-aa9f10dfe9651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53401-005-205340100052020 in 1 BOTTLEHistorical