Ofloxacin

Product NDC
50090-3836
11-digit product format
500903836
Labeler code
50090
Product ID
50090-3836_ce07f542-67d3-4357-be09-f06aae215cf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxaxin
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
A-S Medication Solutions
Application
ANDA076616
Marketing category
ANDA
Marketing start
2008-03-17
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
2022-12-31
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
50090-3836-02023-01-30C16284748780-1f386c64a-3b08-0266-e053-dadaa90a7c1aOfloxacin Otic Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3836-0Ofloxacin5 mL in 1 BOTTLESOLUTION/ DROPS55
50090-3836-0Ofloxacin1 in 1 CARTONSOLUTION/ DROPS15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3836-0ML - Milliliter50090-3836b4dcdaca-8246-4941-9f5d-eeb3bbf46f0d12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3836OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210617_c3996749-2bd9-49bf-9ff8-5b3819459ef3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242446ofloxacin 0.3 % Otic SolutionPSNc3996749-2bd9-49bf-9ff8-5b3819459ef35
242446ofloxacin 3 MG/ML Otic SolutionSCDc3996749-2bd9-49bf-9ff8-5b3819459ef35
242446ofloxacin 0.3 % Otic SolutionSYc3996749-2bd9-49bf-9ff8-5b3819459ef35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3836-0500903836001 BOTTLE in 1 CARTON (50090-3836-0) > 5 mL in 1 BOTTLE1 bottle2018-11-150000-00-00NoNoCurrent