MOXIFLOXACIN

Product NDC
16714-643
11-digit product format
167140643
Labeler code
16714
Product ID
16714-643_c11c970c-ffa6-4661-b515-708bae4eddd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOXIFLOXACIN
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
NorthStar Rx LLC
Application
ANDA206242
Marketing category
ANDA
Marketing start
2017-10-04
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [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
16714-643-01MOXIFLOXACIN3 mL in 1 BOTTLESOLUTION/ DROPS32
16714-643-01MOXIFLOXACIN1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-643-01ML - Milliliter16714-64354e929e5-63c8-4b28-b719-0eb8a70b194512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-643MOXIFLOXACIN SOLUTION/ DROPS [NORTHSTAR RX LLC]2Current NDC, Legacy NDC, 2 package rows20221229_cdc0b0eb-5f56-45c7-b9fd-364752a95ff1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNcdc0b0eb-5f56-45c7-b9fd-364752a95ff12
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDcdc0b0eb-5f56-45c7-b9fd-364752a95ff12
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYcdc0b0eb-5f56-45c7-b9fd-364752a95ff12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-643-01167140643011 BOTTLE in 1 CARTON (16714-643-01) / 3 mL in 1 BOTTLE1 bottle2017-10-040000-00-00NoNoCurrent