Ofloxacin

Product NDC
50436-0713
11-digit product format
504360713
Labeler code
50436
Product ID
50436-0713_386a38f0-f621-43b4-8a85-ef41fd605ef6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Unit Dose Services
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
2020-12-31
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
50436-0713-12021-01-29C16284748780-1ba0f9c33-0e50-a910-e053-dadaa90a0b85PRESCRIBING INFORMATION OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0713-1Ofloxacin1 mL in 1 CARTONSOLUTION/ DROPS12
50436-0713-1Ofloxacin5 in 1 BOTTLE, DROPPERSOLUTION/ DROPS52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0713-1ML - Milliliter50436-0713ae4dbe16-2e64-4af0-9a7f-6be551e8ef3112018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0713OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20180515_71ed7493-f4b2-4e6e-a66c-19740bc7bbd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSN71ed7493-f4b2-4e6e-a66c-19740bc7bbd22
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD71ed7493-f4b2-4e6e-a66c-19740bc7bbd22
312075ofloxacin 0.3 % Ophthalmic SolutionSY71ed7493-f4b2-4e6e-a66c-19740bc7bbd22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-0713-1504360713011 mL in 1 CARTON1 mlHistorical