FDA.reportPublic FDA data

Moxifloxacin

Product NDC
60505-0582
11-digit product format
605050582
Labeler code
60505
Product ID
60505-0582_1f0760bf-4dfb-6466-23d6-72770eecf10e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Apotex Corp.
Application
ANDA090080
Marketing category
ANDA
Marketing start
2017-07-01
Substance
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
Active strength
5 mg/mL
Pharmacologic classes
Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB8956S8609
Rxcui403818

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
84b851da-be59-d750-14d1-e4d93cc3b4daProduct name920250630
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
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
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611
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
60505-0582-4Moxifloxacin1 in 1 CARTONSOLUTION/ DROPS19
60505-0582-4Moxifloxacin3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0582-4ML - Milliliter60505-0582a48c6dfd-2171-4f1c-b8b7-dbc8490978f212017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0582MOXIFLOXACIN SOLUTION/ DROPS [APOTEX CORP.]8Current NDC, Legacy NDC, 2 package rows20240927_8f7a0c4c-34f4-7362-579b-f26c3338f792.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN1cc031d7-0766-41c0-b5b3-35119c850e23101
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD1cc031d7-0766-41c0-b5b3-35119c850e23101
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY1cc031d7-0766-41c0-b5b3-35119c850e23101
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN8f7a0c4c-34f4-7362-579b-f26c3338f7929
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD8f7a0c4c-34f4-7362-579b-f26c3338f7929
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY8f7a0c4c-34f4-7362-579b-f26c3338f7929
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNf19fa89e-9f5d-4eed-e053-2995a90ac3ce3
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN84277117-b228-41ed-a605-bcb532101c3d3
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD84277117-b228-41ed-a605-bcb532101c3d3
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDf19fa89e-9f5d-4eed-e053-2995a90ac3ce3
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY84277117-b228-41ed-a605-bcb532101c3d3
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYf19fa89e-9f5d-4eed-e053-2995a90ac3ce3
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN723771a2-3e9a-e6f3-e053-2a91aa0a4d211
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNe812cc8a-9d03-430f-bc90-07c93837e2501
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN688feb67-9254-4537-b749-9d591fef56371
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD723771a2-3e9a-e6f3-e053-2a91aa0a4d211
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDe812cc8a-9d03-430f-bc90-07c93837e2501
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD688feb67-9254-4537-b749-9d591fef56371
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY723771a2-3e9a-e6f3-e053-2a91aa0a4d211
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY688feb67-9254-4537-b749-9d591fef56371
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYe812cc8a-9d03-430f-bc90-07c93837e2501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0582-4605050582041 BOTTLE, DROPPER in 1 CARTON (60505-0582-4) / 3 mL in 1 BOTTLE, DROPPER2017-07-010000-00-00NoNoCurrent