Ofloxacin

Product NDC
0517-0760
11-digit product format
005170760
Labeler code
0517
Product ID
0517-0760_e4abdf47-d651-478c-be0b-88b2f256023c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
American Regent, Inc.
Application
ANDA076830
Marketing category
ANDA
Marketing start
2010-07-01
Marketing end
0000-00-00
Substance
OFLOXACIN
Active strength
3 mg/mL
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
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0517-0760-012019-10-21C16284748780-1956f9ecf-c04e-621f-e053-dbdaa90a74adOFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% (3 mg/mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-0760-01Ofloxacin5 mL in 1 BOTTLESOLUTION/ DROPS51
0517-0760-01Ofloxacin1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-0760-01ML - Milliliter0517-0760c1dba322-89e1-4316-8805-b44aae3d345412012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-0760OFLOXACIN SOLUTION/ DROPS [AMERICAN REGENT, INC.]1Legacy NDC, 2 package rows20180616_227e11ab-4e07-4e34-b21d-ef965bae6272.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSN227e11ab-4e07-4e34-b21d-ef965bae62721
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD227e11ab-4e07-4e34-b21d-ef965bae62721
312075ofloxacin 0.3 % Ophthalmic SolutionSY227e11ab-4e07-4e34-b21d-ef965bae62721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0517-0760-01005170760015 mL in 1 BOTTLE5 mlHistorical