Moxifloxacin

Product NDC
53217-347
11-digit product format
532170347
Labeler code
53217
Product ID
53217-347_b1bd6471-c51c-49b5-86b4-89bf059208fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA090080
Marketing category
ANDA
Marketing start
2017-11-28
Marketing end
0000-00-00
Substance
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
Active strength
5 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
84b851da-be59-d750-14d1-e4d93cc3b4daProduct name920250630
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-347-01Moxifloxacin3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-347MOXIFLOXACIN SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180815_688feb67-9254-4537-b749-9d591fef5637.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN688feb67-9254-4537-b749-9d591fef56371
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD688feb67-9254-4537-b749-9d591fef56371
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY688feb67-9254-4537-b749-9d591fef56371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-347-01532170347013 mL in 1 BOTTLE, DROPPER3 mlHistorical