Moxifloxacin ophthalmic solution

Product NDC
67296-2222
11-digit product format
672962222
Labeler code
67296
Product ID
67296-2222_4fb56eba-b3d2-acca-e063-6394a90aba1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Redpharm Drug
Application
ANDA217988
Marketing category
ANDA
Marketing start
2025-01-27
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Moxifloxacin ophthalmic solution
Listing expiration
2027-12-31

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
67296-2222-3Moxifloxacin ophthalmic solution1 in 1 CARTONSOLUTION/ DROPS11
67296-2222-3Moxifloxacin ophthalmic solution3 mL in 1 BOTTLESOLUTION/ DROPS31

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN4fb55f17-d9db-8148-e063-6394a90a82161
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD4fb55f17-d9db-8148-e063-6394a90a82161
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY4fb55f17-d9db-8148-e063-6394a90a82161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2222-3672962222031 BOTTLE in 1 CARTON (67296-2222-3) / 3 mL in 1 BOTTLE1 bottle2025-01-27NoNoHistorical