MOXIFLOXACIN

Product NDC
68180-421
11-digit product format
681800421
Labeler code
68180
Product ID
68180-421_29272b83-77cf-4cd1-9aed-b80d0cc6edb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOXIFLOXACIN
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA204079
Marketing category
ANDA
Marketing start
2020-02-13
Substance
MOXIFLOXACIN HYDROCHLORIDE
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 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
68180-421-01MOXIFLOXACIN3 mL in 1 BOTTLESOLUTION37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-421-01ML - Milliliter68180-42197952939-54eb-4db0-82aa-e8833eee8ae612020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-421MOXIFLOXACIN SOLUTION [LUPIN PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20250210_d66f080b-da56-4473-8785-920d9700f72d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNd66f080b-da56-4473-8785-920d9700f72d7
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDd66f080b-da56-4473-8785-920d9700f72d7
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYd66f080b-da56-4473-8785-920d9700f72d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-421-01681800421013 mL in 1 BOTTLE (68180-421-01) 3 ml2020-02-130000-00-00NoNoCurrent