FDA.reportPublic FDA data

Moxifloxacin ophthalmic solution

Product NDC
70756-638
11-digit product format
707560638
Labeler code
70756
Product ID
70756-638_22d5cd84-26c0-49b0-afbf-1e9155749cf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Lifestar Pharma LLC
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Moxifloxacin ophthalmic solution
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
70756-638-25Moxifloxacin ophthalmic solution3 mL in 1 BOTTLESOLUTION/ DROPS34
70756-638-25Moxifloxacin ophthalmic solution1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-638-25ML - Milliliter70756-638fe8ccb1f-494d-402b-b2ca-99b47881068e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-638MOXIFLOXACIN OPHTHALMIC SOLUTION (MOXIFLOXACIN) SOLUTION/ DROPS [LIFESTAR PHARMA LLC]4Current NDC, 2 package rows20250204_ca19b837-8e80-408f-af7b-b0464f20c0c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNca19b837-8e80-408f-af7b-b0464f20c0c34
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDca19b837-8e80-408f-af7b-b0464f20c0c34
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYca19b837-8e80-408f-af7b-b0464f20c0c34
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
70756-638-25707560638251 BOTTLE in 1 CARTON (70756-638-25) / 3 mL in 1 BOTTLE1 bottle2025-01-27NoNoHistorical