Moxifloxacin Hydrochloride

Product NDC
50268-576
11-digit product format
502680576
Labeler code
50268
Product ID
50268-576_4ee2636f-f50a-98d3-e063-6294a90a7e15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA202632
Marketing category
ANDA
Marketing start
2016-07-22
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
50268-576-11Moxifloxacin Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED16
50268-576-13Moxifloxacin Hydrochloride30 in 1 BOX, UNIT-DOSETABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-576MOXIFLOXACIN HYDROCHLORIDE (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AVPAK]4Current NDC, Legacy NDC, 2 package rows20220517_371ca7b2-c62d-ef4b-3076-890b385bfff8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSN371ca7b2-c62d-ef4b-3076-890b385bfff86
311787moxifloxacin 400 MG Oral TabletSCD371ca7b2-c62d-ef4b-3076-890b385bfff86
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY371ca7b2-c62d-ef4b-3076-890b385bfff86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-576-11502680576111 in 1 BLISTER PACKHistorical
50268-576-135026805761330 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-576-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-576-11) 30 blister pack2016-07-220000-00-00NoNoCurrent