Moxifloxacin

Product NDC
66298-8507
11-digit product format
662988507
Labeler code
66298
Product ID
66298-8507_1d783072-b073-e384-e063-6394a90a7460
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOXIFLOXACIN HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hp Halden Pharma AS
Application
NDA205572
Marketing category
NDA
Marketing start
2017-08-02
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
400 mg/250mL
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/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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66298-8507-4Moxifloxacin250 mL in 1 BAGINJECTION, SOLUTION2504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66298-8507MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [HP HALDEN PHARMA AS]4Current NDC, Legacy NDC, 1 package rows20240719_6067b2ee-2171-49bb-aa07-1d401ebf4f2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351156moxifloxacin 400 MG in 250 ML InjectionPSN6067b2ee-2171-49bb-aa07-1d401ebf4f2e4
351156250 ML moxifloxacin 1.6 MG/ML InjectionSCD6067b2ee-2171-49bb-aa07-1d401ebf4f2e4
351156moxifloxacin 400 MG per 250 ML InjectionSY6067b2ee-2171-49bb-aa07-1d401ebf4f2e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66298-8507-466298850704250 mL in 1 BAG (66298-8507-4) 250 ml2017-08-020000-00-00NoNoCurrent