FDA.reportPublic FDA data

Moxifloxacin Hydrochloride Tablets, 400 mg

Product NDC
70518-4312
11-digit product format
705184312
Labeler code
70518
Product ID
70518-4312_402db01e-845f-d529-e063-6394a90a16f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride Tablets, 400 mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208682
Marketing category
ANDA
Marketing start
2025-03-18
Substance
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
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 Tablets, 400 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB8956S8609
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
70518-4312-0Moxifloxacin Hydrochloride Tablets, 400 mg7 in 1 BOTTLE, PLASTICTABLET, FILM COATED73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4312MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG TABLET, FILM COATED [REMEDYREPACK INC.]2Current NDC, 1 package rows20250418_bdb3f89a-01e7-411d-b071-48e87def0873.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSNbdb3f89a-01e7-411d-b071-48e87def08733
311787moxifloxacin 400 MG Oral TabletSCDbdb3f89a-01e7-411d-b071-48e87def08733
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSYbdb3f89a-01e7-411d-b071-48e87def08733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4312-0705184312007 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4312-0) 2025-03-18NoNoHistorical