MOXIFLOXACIN

Product NDC
61919-553
11-digit product format
619190553
Labeler code
61919
Product ID
61919-553_8385abd7-1529-0d7e-e053-2991aa0ac846
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOXIFLOXACIN
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
DIRECT RX
Application
ANDA090080
Marketing category
ANDA
Marketing start
2018-07-30
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
2020-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-553-052025-01-30C16284748780-12cef2736-61c8-d83d-e063-dadaa90ab31fMOXIFLOXACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-553-05MOXIFLOXACIN3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-553-05ML - Milliliter61919-553a7ef0d6e-cb24-43bc-994e-97d73064400d12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-553MOXIFLOXACIN SOLUTION/ DROPS [DIRECT RX]1Legacy NDC, 1 package rows20190402_723771a2-3e9a-e6f3-e053-2a91aa0a4d21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN723771a2-3e9a-e6f3-e053-2a91aa0a4d211
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD723771a2-3e9a-e6f3-e053-2a91aa0a4d211
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY723771a2-3e9a-e6f3-e053-2a91aa0a4d211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-553-05619190553053 mL in 1 BOTTLE, DROPPER (61919-553-05) 3 ml2018-07-300000-00-00NoNoCurrent