VIGAMOX

Product NDC
0078-0939
11-digit product format
000780939
Labeler code
0078
Product ID
0078-0939_5f83352b-a62b-4611-8f74-5826d26749a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA021598
Marketing category
NDA
Marketing start
2003-05-07
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
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0939-26VIGAMOX1 in 1 CARTONSOLUTION/ DROPS13
0078-0939-26VIGAMOX3 mL in 1 BOTTLESOLUTION/ DROPS33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0939-26ML - Milliliter0078-0939300c9d1e-988a-465a-b9a9-ed0b0023362612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0939VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]3Legacy NDC, 2 package rows20230421_ad783689-2b59-448c-b0d6-e8b70cf8b062.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNad783689-2b59-448c-b0d6-e8b70cf8b0623
404473VIGAMOX 0.5 % Ophthalmic SolutionPSNad783689-2b59-448c-b0d6-e8b70cf8b0623
404473moxifloxacin 5 MG/ML Ophthalmic Solution [Vigamox]SBDad783689-2b59-448c-b0d6-e8b70cf8b0623
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDad783689-2b59-448c-b0d6-e8b70cf8b0623
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYad783689-2b59-448c-b0d6-e8b70cf8b0623
404473Vigamox 0.5 % Ophthalmic SolutionSYad783689-2b59-448c-b0d6-e8b70cf8b0623
404473Vigamox 5 MG/ML Ophthalmic SolutionSYad783689-2b59-448c-b0d6-e8b70cf8b0623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0939-26000780939261 BOTTLE in 1 CARTON (0078-0939-26) > 3 mL in 1 BOTTLE1 bottle2021-08-120000-00-00NoNoCurrent