FDA.reportPublic FDA data

Moxifloxacin Hydrochloride Tablets, 400 mg

Product NDC
72789-080
11-digit product format
727890080
Labeler code
72789
Product ID
72789-080_40319333-cf76-1664-e063-6294a90ae7e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride Tablets, 400 mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA208682
Marketing category
ANDA
Marketing start
2018-07-21
Substance
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
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 Hydrochloride Tablets, 400 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB8956S8609
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
72789-080-10Moxifloxacin Hydrochloride Tablets, 400 mg10 in 1 BOTTLE, PLASTICTABLET, FILM COATED109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-080-10EA - Each72789-0807f6c6175-a7de-416e-8ee7-f2c0ca2e97e212020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-080MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 1 package rows20241010_5c2a9116-d6e4-429e-88bb-bb6bfedac2f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSN5c2a9116-d6e4-429e-88bb-bb6bfedac2f09
311787moxifloxacin 400 MG Oral TabletSCD5c2a9116-d6e4-429e-88bb-bb6bfedac2f09
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY5c2a9116-d6e4-429e-88bb-bb6bfedac2f09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-080-107278900801010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-080-10) 2020-04-100000-00-00NoNoCurrent