MOXIFLOXACIN HYDROCHLORIDE

Product NDC
67457-323
11-digit product format
674570323
Labeler code
67457
Product ID
67457-323_4719ed2a-9c0b-466a-90ee-a5f9f305cd02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOXIFLOXACIN HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA205833
Marketing category
ANDA
Marketing start
2017-10-03
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
400 mg/250mL
Pharmacologic classes
Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MOXIFLOXACIN HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE400 mg/250mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC53598599T
Rxcui351156

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
67457-323-25MOXIFLOXACIN HYDROCHLORIDE250 mL in 1 BAGINJECTION, SOLUTION2509
67457-323-25MOXIFLOXACIN HYDROCHLORIDE1 in 1 CARTONINJECTION, SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-323-25ML - Milliliter67457-3234314e789-3f22-4a21-833d-7ebeda4aebbf12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-323MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]5Current NDC, Legacy NDC, 2 package rows20240702_c6fa4129-2f92-4179-ac5d-bb7b4a538789.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351156moxifloxacin 400 MG in 250 ML InjectionPSNc6fa4129-2f92-4179-ac5d-bb7b4a5387899
351156250 ML moxifloxacin 1.6 MG/ML InjectionSCDc6fa4129-2f92-4179-ac5d-bb7b4a5387899
351156moxifloxacin 400 MG per 250 ML InjectionSYc6fa4129-2f92-4179-ac5d-bb7b4a5387899

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-323-25674570323251 BAG in 1 CARTON (67457-323-25) / 250 mL in 1 BAG1 bag2017-10-030000-00-00NoNoCurrent