FDA.reportPublic FDA data

Moxifloxacin Hydrochloride

Product NDC
40032-034
11-digit product format
400320034
Labeler code
40032
Product ID
40032-034_d08822f4-a3b8-4df1-8ca7-b5f97e4d5c65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA207285
Marketing category
ANDA
Marketing start
2017-02-13
Marketing end
0000-00-00
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40032-034-032024-01-30C16284748780-11030e365-329a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MOXIFLOXACIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MOXIFLOXACIN HYDROCHLORIDE TABLETS. MOXIFLOXACIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval:1999
40032-034-052024-01-30C16284748780-11030e365-329a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MOXIFLOXACIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MOXIFLOXACIN HYDROCHLORIDE TABLETS. MOXIFLOXACIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval:1999
40032-034-312024-01-30C16284748780-11030e365-329a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MOXIFLOXACIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MOXIFLOXACIN HYDROCHLORIDE TABLETS. MOXIFLOXACIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval:1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-034-03Moxifloxacin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET305
40032-034-05Moxifloxacin Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5005
40032-034-31Moxifloxacin Hydrochloride10 in 1 BLISTER PACKTABLET105
40032-034-31Moxifloxacin Hydrochloride5 in 1 CARTONTABLET55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-034MOXIFLOXACIN HYDROCHLORIDE TABLET [NOVEL LABORATORIES, INC.]5Legacy NDC, 4 package rows20191222_3c442cca-47f5-48e5-b718-c09413911687.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSN3c442cca-47f5-48e5-b718-c094139116875
311787moxifloxacin 400 MG Oral TabletSCD3c442cca-47f5-48e5-b718-c094139116875
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY3c442cca-47f5-48e5-b718-c094139116875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-034-034003200340330 TABLET in 1 BOTTLE, PLASTIC (40032-034-03) 30 tablet2017-02-130000-00-00NoNoCurrent
40032-034-0540032003405500 TABLET in 1 BOTTLE, PLASTIC (40032-034-05) 500 tablet2017-02-130000-00-00NoNoCurrent
40032-034-31400320034315 BLISTER PACK in 1 CARTON (40032-034-31) > 10 TABLET in 1 BLISTER PACK5 blister pack2017-02-130000-00-00NoNoCurrent