FDA.reportPublic FDA data

Moxifloxacin ophthalmic solution

Product NDC
50090-4781
11-digit product format
500904781
Labeler code
50090
Product ID
50090-4781_7bb7b81f-241e-471c-92bd-daf69035980a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin ophthalmic
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA209469
Marketing category
ANDA
Marketing start
2019-02-13
Substance
MOXIFLOXACIN HYDROCHLORIDE
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 ophthalmic solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC53598599T
Rxcui403818

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4781-0Moxifloxacin ophthalmic solution1 in 1 CARTONSOLUTION/ DROPS17
50090-4781-0Moxifloxacin ophthalmic solution3 mL in 1 BOTTLESOLUTION/ DROPS37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4781-0ML - Milliliter50090-4781ff8e2e85-8d59-482a-9a5a-aff5ac8b324a12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4781MOXIFLOXACIN OPHTHALMIC SOLUTION (MOXIFLOXACIN OPHTHALMIC) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20231216_e33b3315-54f6-47ce-8a4f-3b79be408540.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNe33b3315-54f6-47ce-8a4f-3b79be4085407
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDe33b3315-54f6-47ce-8a4f-3b79be4085407
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYe33b3315-54f6-47ce-8a4f-3b79be4085407

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4781-0500904781001 BOTTLE in 1 CARTON (50090-4781-0) / 3 mL in 1 BOTTLE1 bottle2019-12-050000-00-00NoNoCurrent