FDA.reportPublic FDA data

Moxifloxacin Hydrochloride Tablets, 400 mg

Product NDC
72205-001
11-digit product format
722050001
Labeler code
72205
Product ID
72205-001_79a88ea4-ddf4-4ee9-acc2-91047ce636d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride Tablets, 400 mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA208682
Marketing category
ANDA
Marketing start
2018-07-21
Substance
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
Active strength
400 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [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 Tablets, 400 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB8956S8609
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
72205-001-05Moxifloxacin Hydrochloride Tablets, 400 mg500 in 1 BOTTLETABLET, FILM COATED5003
72205-001-11Moxifloxacin Hydrochloride Tablets, 400 mg10 in 1 BLISTER PACKTABLET, FILM COATED103
72205-001-30Moxifloxacin Hydrochloride Tablets, 400 mg30 in 1 BOTTLETABLET, FILM COATED303
72205-001-31Moxifloxacin Hydrochloride Tablets, 400 mg50 in 1 CARTONTABLET, FILM COATED503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-001-05EA - Each72205-0017fe24396-1128-4bc2-9459-98d237537c5812018-10-11
72205-001-30EA - Each72205-001054403b8-c1dd-4c8a-9f92-f2cbc173652c12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-001MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 4 package rows20190504_04e0936f-2248-48e4-8031-ac6ccc2df294.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSN5c2a9116-d6e4-429e-88bb-bb6bfedac2f09
311787moxifloxacin 400 MG Oral TabletSCD5c2a9116-d6e4-429e-88bb-bb6bfedac2f09
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY5c2a9116-d6e4-429e-88bb-bb6bfedac2f09
311787moxifloxacin HCl 400 MG Oral TabletPSN04e0936f-2248-48e4-8031-ac6ccc2df2943
311787moxifloxacin HCl 400 MG Oral TabletPSNbdb3f89a-01e7-411d-b071-48e87def08733
311787moxifloxacin 400 MG Oral TabletSCD04e0936f-2248-48e4-8031-ac6ccc2df2943
311787moxifloxacin 400 MG Oral TabletSCDbdb3f89a-01e7-411d-b071-48e87def08733
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY04e0936f-2248-48e4-8031-ac6ccc2df2943
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSYbdb3f89a-01e7-411d-b071-48e87def08733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-001-0572205000105500 TABLET, FILM COATED in 1 BOTTLE (72205-001-05) 2019-04-160000-00-00NoNoCurrent
72205-001-117220500011110 in 1 BLISTER PACKHistorical
72205-001-307220500013030 TABLET, FILM COATED in 1 BOTTLE (72205-001-30) 2019-04-160000-00-00NoNoCurrent
72205-001-317220500013150 BLISTER PACK in 1 CARTON (72205-001-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-001-11) 50 blister pack2019-04-160000-00-00NoNoCurrent