Moxifloxacin

Product NDC
67296-2129
11-digit product format
672962129
Labeler code
67296
Product ID
67296-2129_4698d4e7-2e86-6fbf-e063-6294a90a0d1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Redpharm Drug
Application
ANDA202867
Marketing category
ANDA
Marketing start
2017-07-01
Substance
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB8956S8609
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
67296-2129-3Moxifloxacin1 in 1 CARTONSOLUTION/ DROPS14
67296-2129-3Moxifloxacin3 mL in 1 BOTTLESOLUTION/ DROPS34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-2129MOXIFLOXACIN SOLUTION/ DROPS [REDPHARM DRUG]1Current NDC, 2 package rows20250313_301eef74-16db-14aa-e063-6294a90ac8ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN301eef74-16db-14aa-e063-6294a90ac8ff4
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD301eef74-16db-14aa-e063-6294a90ac8ff4
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY301eef74-16db-14aa-e063-6294a90ac8ff4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2129-3672962129031 BOTTLE in 1 CARTON (67296-2129-3) / 3 mL in 1 BOTTLE1 bottle2017-07-01NoNoHistorical