FDA.reportPublic FDA data

Moxifloxacin Ophthalmic Solution

Product NDC
72266-158
11-digit product format
722660158
Labeler code
72266
Product ID
72266-158_3a227739-e57d-10aa-e063-6294a90ac95e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Ophthalmic
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Fosun Pharma USA Inc.
Application
ANDA208778
Marketing category
ANDA
Marketing start
2020-08-24
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
72266-158-01Moxifloxacin Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS13
72266-158-01Moxifloxacin Ophthalmic Solution3 mL in 1 BOTTLESOLUTION/ DROPS33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-158MOXIFLOXACIN OPHTHALMIC SOLUTION (MOXIFLOXACIN OPHTHALMIC) SOLUTION/ DROPS [FOSUN PHARMA USA INC.]2Current NDC, Legacy NDC, 2 package rows20240518_9eae534a-9253-4a45-9ab7-2543626f49e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN9eae534a-9253-4a45-9ab7-2543626f49e63
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNc76f7d78-1e52-4557-a43b-cfc8e5842c803
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD9eae534a-9253-4a45-9ab7-2543626f49e63
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDc76f7d78-1e52-4557-a43b-cfc8e5842c803
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY9eae534a-9253-4a45-9ab7-2543626f49e63
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYc76f7d78-1e52-4557-a43b-cfc8e5842c803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-158-01722660158011 BOTTLE in 1 CARTON (72266-158-01) / 3 mL in 1 BOTTLE1 bottle2020-08-240000-00-00NoNoCurrent