Ciprofloxacin

Product NDC
53401-004
11-digit product format
534010004
Labeler code
53401
Product ID
53401-004_71ae692b-b996-4498-b7f0-15acb582f497
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Testpak Holding Company
Application
ANDA007581
Marketing category
ANDA
Marketing start
2009-10-10
Marketing end
0000-00-00
Substance
CIPROFLOXACIN
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
53401-004-202019-10-21C16284748780-1956f9ecf-cba3-621f-e053-dbdaa90a74adCIPROFLOXACIN 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53401-004-20Ciprofloxacin20 in 1 BOTTLETABLET, COATED201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CiprofloxacinACTIVE INGREDIENT5E8K9I0O4UCIPROFLOXACIN TABLET, COATED [TESTPAK HOLDING COMPANY]1
CiprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, COATED [TESTPAK HOLDING COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53401-004CIPROFLOXACIN TABLET, COATED [TESTPAK HOLDING COMPANY]1Legacy NDC, 1 package rows20100224_6f41228b-974a-443b-a313-2fbb3d845915.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN6f41228b-974a-443b-a313-2fbb3d8459151
309309ciprofloxacin 500 MG Oral TabletSCD6f41228b-974a-443b-a313-2fbb3d8459151
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY6f41228b-974a-443b-a313-2fbb3d8459151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53401-004-205340100042020 in 1 BOTTLEHistorical