Moxifloxacin Hydrochloride

Product NDC
70518-4458
11-digit product format
705184458
Labeler code
70518
Product ID
70518-4458_3d584177-4ca7-3709-e063-6394a90abdaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202632
Marketing category
ANDA
Marketing start
2025-08-27
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
70518-4458-0Moxifloxacin Hydrochloride7 in 1 BOTTLE, PLASTICTABLET, FILM COATED71

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSN54377276-96bf-4140-9e90-55623ab6b0131
311787moxifloxacin 400 MG Oral TabletSCD54377276-96bf-4140-9e90-55623ab6b0131
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY54377276-96bf-4140-9e90-55623ab6b0131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4458-0705184458007 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4458-0) 2025-08-27NoNoCurrent