Moxifloxacin Hydrochloride

Product NDC
51991-943
11-digit product format
519910943
Labeler code
51991
Product ID
51991-943_16ed9147-1f04-4907-bc63-2a46ba201cc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA205348
Marketing category
ANDA
Marketing start
2017-05-02
Marketing end
0000-00-00
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-943-33EA - Each51991-943a8e2745a-7f66-4245-9c68-2c716d6b740412017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-943MOXIFLOXACIN HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]11Legacy NDC20230617_4bcacdca-c1cf-234c-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-943-335199109433330 TABLET in 1 BOTTLE (51991-943-33) 30 tablet2017-05-020000-00-00NoNoCurrent