FDA.reportPublic FDA data

Moxifloxacin Ophthalmic Solution

Product NDC
0781-7135
11-digit product format
007817135
Labeler code
0781
Product ID
0781-7135_fe09f635-c4f0-4698-8468-d226257b6d58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
NDA021598
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2003-05-07
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-7135-932020-02-28C16284748780-19d75b9d0-082f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MOXIFLOXACIN OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for MOXIFLOXACIN OPHTHALMIC SOLUTION. MOXIFLOXACIN ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 1999
0781-7135-932020-01-31C16284748780-19d75b9d0-082f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MOXIFLOXACIN OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for MOXIFLOXACIN OPHTHALMIC SOLUTION. MOXIFLOXACIN ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-7135-93Moxifloxacin Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS13
0781-7135-93Moxifloxacin Ophthalmic Solution3 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-7135-93ML - Milliliter0781-713587b77896-4559-469b-b804-f2efcebdd7cd12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-7135MOXIFLOXACIN OPHTHALMIC SOLUTION (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION/ DROPS [SANDOZ INC]3Current NDC, Legacy NDC, 2 package rows20200714_fc88791b-24da-48a4-85f5-93a8af3d0b51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNfc88791b-24da-48a4-85f5-93a8af3d0b513
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDfc88791b-24da-48a4-85f5-93a8af3d0b513
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYfc88791b-24da-48a4-85f5-93a8af3d0b513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-7135-93007817135931 BOTTLE, PLASTIC in 1 CARTON (0781-7135-93) / 3 mL in 1 BOTTLE, PLASTIC2017-06-300000-00-00NoNoCurrent