Moxifloxacin

Product NDC
51407-321
11-digit product format
514070321
Labeler code
51407
Product ID
51407-321_462c4ec2-869f-68a8-e063-6394a90a62f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Golden State Medical Supply, Inc.
Application
ANDA090080
Marketing category
ANDA
Marketing start
2017-06-30
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
51407-321-03Moxifloxacin3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS33
51407-321-03Moxifloxacin1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-321MOXIFLOXACIN SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, 2 package rows20241213_f9dff08a-edb2-86de-e053-6394a90a1043.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNf9dff08a-edb2-86de-e053-6394a90a10433
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDf9dff08a-edb2-86de-e053-6394a90a10433
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYf9dff08a-edb2-86de-e053-6394a90a10433

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-321-03514070321031 BOTTLE, DROPPER in 1 CARTON (51407-321-03) / 3 mL in 1 BOTTLE, DROPPER2023-04-21NoNoCurrent