FDA.reportPublic FDA data

MOXIFLOXACIN HYDROCHLORIDE

Product NDC
0904-7407
11-digit product format
009047407
Labeler code
0904
Product ID
0904-7407_eeab280e-fdca-45ae-b2ae-325799c9c3ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA202632
Marketing category
ANDA
Marketing start
2024-03-08
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 HYDROCHLORIDE
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
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7407-04MOXIFLOXACIN HYDROCHLORIDE30 in 1 CARTONTABLET, FILM COATED303
0904-7407-04MOXIFLOXACIN HYDROCHLORIDE1 in 1 BLISTER PACKTABLET, FILM COATED13
0904-7407-06MOXIFLOXACIN HYDROCHLORIDE50 in 1 CARTONTABLET, FILM COATED503
0904-7407-06MOXIFLOXACIN HYDROCHLORIDE1 in 1 BLISTER PACKTABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7407-04EA - Each0904-7407e241162d-1ca1-49b9-8ea4-6ef61e589ec912024-05-16
0904-7407-06EA - Each0904-7407c5589244-e713-4d6e-869d-a8119472a82f12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7407MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2Current NDC, 4 package rows20250122_815d71cf-02de-4190-9bd1-3fdc67ef0f06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSN815d71cf-02de-4190-9bd1-3fdc67ef0f063
311787moxifloxacin 400 MG Oral TabletSCD815d71cf-02de-4190-9bd1-3fdc67ef0f063
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY815d71cf-02de-4190-9bd1-3fdc67ef0f063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7407-040090474070430 BLISTER PACK in 1 CARTON (0904-7407-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2024-03-08NoNoHistorical
0904-7407-060090474070650 BLISTER PACK in 1 CARTON (0904-7407-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2024-03-08NoNoHistorical