Ofloxacin

Product NDC
68071-2834
11-digit product format
680712834
Labeler code
68071
Product ID
68071-2834_ef54fd2a-df63-ba37-e053-2a95a90aafb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076407
Marketing category
ANDA
Marketing start
2008-07-01
Marketing end
0000-00-00
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f9d82093-3de1-4841-9a42-67222d61a0cfProduct name420250515
bbed5f06-a6b7-a443-70ac-77518a9524b7Product name720250311
41679fed-052c-574b-6b40-cadcbc315b79Product name220150401

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2834-12025-01-30C16284748780-12cef2736-b1c0-d83d-e063-dadaa90ab31fPRESCRIBING INFORMATION OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2834-1Ofloxacin1 in 1 CARTONSOLUTION/ DROPS11
68071-2834-1Ofloxacin10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2834OFLOXACIN SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20221209_ef54fd2a-df62-ba37-e053-2a95a90aafb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSNef54fd2a-df62-ba37-e053-2a95a90aafb71
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDef54fd2a-df62-ba37-e053-2a95a90aafb71
312075ofloxacin 0.3 % Ophthalmic SolutionSYef54fd2a-df62-ba37-e053-2a95a90aafb71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2834-1680712834011 BOTTLE, DROPPER in 1 CARTON (68071-2834-1) > 10 mL in 1 BOTTLE, DROPPER2022-12-080000-00-00NoNoCurrent