FDA.reportPublic FDA data

Ofloxacin

Product NDC
72485-613
11-digit product format
724850613
Labeler code
72485
Product ID
72485-613_086cc6db-b800-dc8f-e063-6294a90a4196
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
ARMAS PHARMACEUTICALS INC.
Application
ANDA076407
Marketing category
ANDA
Marketing start
2023-10-14
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OFLOXACIN3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA4P49JAZ9H
Rxcui312075

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f9d82093-3de1-4841-9a42-67222d61a0cfProduct name420250515
bbed5f06-a6b7-a443-70ac-77518a9524b7Product name720250311
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
41679fed-052c-574b-6b40-cadcbc315b79Product name220150401
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-613-10Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS52
72485-613-10Ofloxacin1 in 1 CARTONSOLUTION/ DROPS12
72485-613-11Ofloxacin10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS102
72485-613-11Ofloxacin1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-613OFLOXACIN SOLUTION/ DROPS [ARMAS PHARMACEUTICALS INC.]2Current NDC, 4 package rows20231025_07ac850b-a983-fc21-e063-6394a90a21b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSN07ac850b-a983-fc21-e063-6394a90a21b22
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD07ac850b-a983-fc21-e063-6394a90a21b22
312075ofloxacin 0.3 % Ophthalmic SolutionSY07ac850b-a983-fc21-e063-6394a90a21b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72485-613-10724850613101 BOTTLE, DROPPER in 1 CARTON (72485-613-10) / 5 mL in 1 BOTTLE, DROPPER2023-10-14NoNoCurrent
72485-613-11724850613111 BOTTLE, DROPPER in 1 CARTON (72485-613-11) / 10 mL in 1 BOTTLE, DROPPER2023-10-14NoNoCurrent