Moxifloxacin Hydrochloride

Product NDC
67296-2232
11-digit product format
672962232
Labeler code
67296
Product ID
67296-2232_51d45c8d-c77e-d974-e063-6394a90ac72c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Redpharm Drug
Application
ANDA209698
Marketing category
ANDA
Marketing start
2024-11-25
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 Hydrochloride
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
67296-2232-3Moxifloxacin Hydrochloride1 in 1 CARTONSOLUTION/ DROPS11
67296-2232-3Moxifloxacin Hydrochloride3 mL in 1 BOTTLESOLUTION/ DROPS31

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN51d45346-5506-d2c9-e063-6394a90ae6bb1
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD51d45346-5506-d2c9-e063-6394a90ae6bb1
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY51d45346-5506-d2c9-e063-6394a90ae6bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2232-3672962232031 BOTTLE in 1 CARTON (67296-2232-3) / 3 mL in 1 BOTTLE1 bottle2024-11-25NoNoCurrent