FDA.reportPublic FDA data

Moxifloxacin Hydrochloride

Product NDC
57237-156
11-digit product format
572370156
Labeler code
57237
Product ID
57237-156_20ac52fe-93eb-47c8-8bab-37f745f795fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Moxifloxacin Hydrochloride
Listing expiration
2026-12-31

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
57237-156-30Moxifloxacin Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-156-30EA - Each57237-156303816b6-259d-48e5-99ec-800159d763fa12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MOXIFLOXACIN HYDROCHLORIDEACTIVE INGREDIENTC53598599TMOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]1
MOXIFLOXACINACTIVE MOIETYU188XYD42PMOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-156MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]11Current NDC, Legacy NDC, 1 package rows20241009_f34c08e6-fe74-4de3-9e36-a82c3c1c183b.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
311787moxifloxacin HCl 400 MG Oral TabletPSNf34c08e6-fe74-4de3-9e36-a82c3c1c183b12
311787moxifloxacin 400 MG Oral TabletSCDf34c08e6-fe74-4de3-9e36-a82c3c1c183b12
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSYf34c08e6-fe74-4de3-9e36-a82c3c1c183b12
311787moxifloxacin HCl 400 MG Oral TabletPSNc71e5987-edd7-4c38-b646-3e48a6e51bf45
311787moxifloxacin 400 MG Oral TabletSCDc71e5987-edd7-4c38-b646-3e48a6e51bf45
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSYc71e5987-edd7-4c38-b646-3e48a6e51bf45
311787moxifloxacin HCl 400 MG Oral TabletPSN6cbcf4d7-85c8-f744-e053-2a91aa0a2ae13
311787moxifloxacin 400 MG Oral TabletSCD6cbcf4d7-85c8-f744-e053-2a91aa0a2ae13
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY6cbcf4d7-85c8-f744-e053-2a91aa0a2ae13
311787moxifloxacin HCl 400 MG Oral TabletPSN37466c79-8726-4fd6-9412-0bb83d523fe31
311787moxifloxacin HCl 400 MG Oral TabletPSNac8a81b9-2fed-412a-8c83-db8dee1061f61
311787moxifloxacin HCl 400 MG Oral TabletPSN54377276-96bf-4140-9e90-55623ab6b0131
311787moxifloxacin 400 MG Oral TabletSCDac8a81b9-2fed-412a-8c83-db8dee1061f61
311787moxifloxacin 400 MG Oral TabletSCD54377276-96bf-4140-9e90-55623ab6b0131
311787moxifloxacin 400 MG Oral TabletSCD37466c79-8726-4fd6-9412-0bb83d523fe31
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSYac8a81b9-2fed-412a-8c83-db8dee1061f61
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY54377276-96bf-4140-9e90-55623ab6b0131
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY37466c79-8726-4fd6-9412-0bb83d523fe31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-156-305723701563030 TABLET, FILM COATED in 1 BOTTLE (57237-156-30) 2014-03-040000-00-00NoNoCurrent