Moxifloxacin Hydrochloride

Product NDC
50090-6609
11-digit product format
500906609
Labeler code
50090
Product ID
50090-6609_20c49868-6dc2-4951-8729-16b51689c387
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-6609-0Moxifloxacin Hydrochloride10 in 1 BOTTLETABLET, FILM COATED105
50090-6609-1Moxifloxacin Hydrochloride7 in 1 BOTTLETABLET, FILM COATED75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6609-0EA - Each50090-6609e88d6f70-c421-4730-9691-4cfb66b81b5512023-10-16
50090-6609-1EA - Each50090-6609f5b4aad5-43e7-4828-ac8a-fd1f84e010f612023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6609MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, 2 package rows20231115_c71e5987-edd7-4c38-b646-3e48a6e51bf4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6609-05009066090010 TABLET, FILM COATED in 1 BOTTLE (50090-6609-0) 2023-08-23NoNoCurrent
50090-6609-1500906609017 TABLET, FILM COATED in 1 BOTTLE (50090-6609-1) 2023-10-31NoNoCurrent