Moxifloxacin Hydrochloride

Product NDC
72789-350
11-digit product format
727890350
Labeler code
72789
Product ID
72789-350_4bbf366b-77ca-fc66-e063-6394a90aebf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA202632
Marketing category
ANDA
Marketing start
2014-03-04
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Moxifloxacin Hydrochloride
Listing expiration
2027-12-31

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
72789-350-10Moxifloxacin Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-350MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12Current NDC, 1 package rows20250406_be5b7a6f-9ee3-4453-807e-4761fffff60c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSNbe5b7a6f-9ee3-4453-807e-4761fffff60c13
311787moxifloxacin 400 MG Oral TabletSCDbe5b7a6f-9ee3-4453-807e-4761fffff60c13
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSYbe5b7a6f-9ee3-4453-807e-4761fffff60c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-350-107278903501010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-350-10) 2023-09-15NoNoHistorical