FDA.reportPublic FDA data

MOXIFLOXACIN HYDROCHLORIDE

Product NDC
71335-2329
11-digit product format
713352329
Labeler code
71335
Product ID
71335-2329_27333e37-8b1e-4ce0-98de-f0dfcbb773e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-2329-1MOXIFLOXACIN HYDROCHLORIDE7 in 1 BOTTLETABLET, FILM COATED7104
71335-2329-2MOXIFLOXACIN HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED10104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2329MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, 2 package rows20241019_6cd420c3-113e-4fc2-b59f-bfc7c485c14d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSN6cd420c3-113e-4fc2-b59f-bfc7c485c14d104
311787moxifloxacin 400 MG Oral TabletSCD6cd420c3-113e-4fc2-b59f-bfc7c485c14d104
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY6cd420c3-113e-4fc2-b59f-bfc7c485c14d104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2329-1713352329017 TABLET, FILM COATED in 1 BOTTLE (71335-2329-1) 2024-10-04NoNoHistorical
71335-2329-27133523290210 TABLET, FILM COATED in 1 BOTTLE (71335-2329-2) 2024-01-03NoNoHistorical