Moxifloxacin

Product NDC
73473-903
11-digit product format
734730903
Labeler code
73473
Product ID
73473-903_45ce210f-125d-12f6-e063-6394a90a9f9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Solaris Pharma Corporation
Application
ANDA206295
Marketing category
ANDA
Marketing start
2025-12-12
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
400 mg/1
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 HYDROCHLORIDE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC53598599T
Rxcui311787

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
84b851da-be59-d750-14d1-e4d93cc3b4daProduct name920250630
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73473-903-30Moxifloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73473-903-30EA - Each73473-9038608f447-ced0-42f6-b35e-06551169415b12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSN45ce14e5-98b8-296b-e063-6294a90a769b1
311787moxifloxacin 400 MG Oral TabletSCD45ce14e5-98b8-296b-e063-6294a90a769b1
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY45ce14e5-98b8-296b-e063-6294a90a769b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73473-903-307347309033030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73473-903-30) 2025-12-12NoNoHistorical