MOXIFLOXACIN HYDROCHLORIDE

Product NDC
70518-3738
11-digit product format
705183738
Labeler code
70518
Product ID
70518-3738_5217ad4c-ce24-c036-e063-6394a90abd2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202632
Marketing category
ANDA
Marketing start
2023-05-30
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 HYDROCHLORIDE
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
70518-3738-0MOXIFLOXACIN HYDROCHLORIDE7 in 1 BOTTLE, PLASTICTABLET, FILM COATED79

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3738MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, 1 package rows20250215_bd0c0690-ba48-41c5-b76b-b1a53c36f424.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311787moxifloxacin HCl 400 MG Oral TabletPSNbd0c0690-ba48-41c5-b76b-b1a53c36f4249
311787moxifloxacin 400 MG Oral TabletSCDbd0c0690-ba48-41c5-b76b-b1a53c36f4249
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSYbd0c0690-ba48-41c5-b76b-b1a53c36f4249

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3738-0705183738007 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3738-0) 2023-05-30NoNoHistorical