Moxifloxacin

Product NDC
63629-8357
11-digit product format
636298357
Labeler code
63629
Product ID
63629-8357_27864513-a113-4ec1-9e78-41bc762172bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076938
Marketing category
ANDA
Marketing start
2014-03-05
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
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
63629-8357-1Moxifloxacin7 in 1 BOTTLETABLET, FILM COATED7104
63629-8357-2Moxifloxacin10 in 1 BOTTLETABLET, FILM COATED10104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8357MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20231109_d20ba997-30de-445c-8766-924112bd834a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSNd20ba997-30de-445c-8766-924112bd834a104
311787moxifloxacin 400 MG Oral TabletSCDd20ba997-30de-445c-8766-924112bd834a104
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSYd20ba997-30de-445c-8766-924112bd834a104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8357-1636298357017 TABLET, FILM COATED in 1 BOTTLE (63629-8357-1) 2020-09-170000-00-00NoNoCurrent
63629-8357-26362983570210 TABLET, FILM COATED in 1 BOTTLE (63629-8357-2) 2020-11-050000-00-00NoNoCurrent