Moxifloxacin

Product NDC
33342-322
11-digit product format
333420322
Labeler code
33342
Product ID
33342-322_db1f06dd-34a6-410c-ab73-acc3c57e78dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA209143
Marketing category
ANDA
Marketing start
2026-03-02
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
400 mg/1
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
Listing expiration
2027-12-31

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
33342-322-07Moxifloxacin30 in 1 BOTTLETABLET, FILM COATED302
33342-322-12Moxifloxacin10 in 1 BLISTER PACKTABLET, FILM COATED102
33342-322-12Moxifloxacin10 in 1 CARTONTABLET, FILM COATED102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSN182ecd0f-714f-42f0-9b16-fb604cf157862
311787moxifloxacin 400 MG Oral TabletSCD182ecd0f-714f-42f0-9b16-fb604cf157862
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY182ecd0f-714f-42f0-9b16-fb604cf157862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-322-073334203220730 TABLET, FILM COATED in 1 BOTTLE (33342-322-07) 2026-03-02NoNoHistorical
33342-322-123334203221210 BLISTER PACK in 1 CARTON (33342-322-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2026-03-02NoNoHistorical