Moxifloxacin

Product NDC
0378-5430
11-digit product format
003785430
Labeler code
0378
Product ID
0378-5430_df168a81-9f81-440b-b0bc-50006aea42b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA206447
Marketing category
ANDA
Marketing start
2020-05-28
Marketing end
0000-00-00
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5430-35ML - Milliliter0378-5430cdb55f49-fd79-4e1a-9271-ce2dd64b793812020-06-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-5430-35003785430351 BOTTLE in 1 CARTON (0378-5430-35) > 3 mL in 1 BOTTLE1 bottle2020-05-280000-00-00NoNoCurrent