FDA.reportPublic FDA data

Moxifloxacin Hydrochloride

Product NDC
0832-1410
11-digit product format
008321410
Labeler code
0832
Product ID
0832-1410_b740604e-1d7a-4382-90ca-26b0186f7a93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA212616
Marketing category
ANDA
Marketing start
2021-02-10
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 Hydrochloride
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
0832-1410-03Moxifloxacin Hydrochloride1 in 1 CARTONSOLUTION15
0832-1410-03Moxifloxacin Hydrochloride3 mL in 1 BOTTLE, PLASTICSOLUTION35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-1410-03ML - Milliliter0832-1410e817f6f2-e94a-4282-9ae6-46253aeee20612021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-1410MOXIFLOXACIN HYDROCHLORIDE SOLUTION [UPSHER-SMITH LABORATORIES, LLC]5Current NDC, Legacy NDC, 2 package rows20230531_5a5d72e2-aa39-4ead-af72-d3cabe72a5b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN5a5d72e2-aa39-4ead-af72-d3cabe72a5b75
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD5a5d72e2-aa39-4ead-af72-d3cabe72a5b75
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY5a5d72e2-aa39-4ead-af72-d3cabe72a5b75
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN8f92f110-32d6-4d0c-a415-7a9a4cafb9b81
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD8f92f110-32d6-4d0c-a415-7a9a4cafb9b81
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY8f92f110-32d6-4d0c-a415-7a9a4cafb9b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0832-1410-03008321410031 BOTTLE, PLASTIC in 1 CARTON (0832-1410-03) / 3 mL in 1 BOTTLE, PLASTIC2021-02-100000-00-00NoNoCurrent