Moxifloxacin

Product NDC
31722-845
11-digit product format
317220845
Labeler code
31722
Product ID
31722-845_40b874c7-8b88-6a93-e063-6394a90ad44f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA204836
Marketing category
ANDA
Marketing start
2023-03-02
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
31722-845-05Moxifloxacin500 in 1 BOTTLETABLET, FILM COATED5004
31722-845-30Moxifloxacin30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-845MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]3Current NDC, 2 package rows20230316_1e6bc886-eec9-4cd8-be78-7563817457f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSN1e6bc886-eec9-4cd8-be78-7563817457f24
311787moxifloxacin 400 MG Oral TabletSCD1e6bc886-eec9-4cd8-be78-7563817457f24
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY1e6bc886-eec9-4cd8-be78-7563817457f24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-845-0531722084505500 TABLET, FILM COATED in 1 BOTTLE (31722-845-05) 2023-03-02NoNoCurrent
31722-845-303172208453030 TABLET, FILM COATED in 1 BOTTLE (31722-845-30) 2023-03-02NoNoCurrent