Moxifloxacin ophthalmic solution

Product NDC
53002-2626
11-digit product format
530022626
Labeler code
53002
Product ID
53002-2626_789328a3-230a-4eea-9a7e-1824f15c74ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin ophthalmic
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA209469
Marketing category
ANDA
Marketing start
2019-02-13
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 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
53002-2626-1Moxifloxacin ophthalmic solution3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2626MOXIFLOXACIN OPHTHALMIC SOLUTION (MOXIFLOXACIN OPHTHALMIC) SOLUTION/ DROPS [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20230609_9c720895-f7a4-4e74-b5f2-a63ecf54887e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN9c720895-f7a4-4e74-b5f2-a63ecf54887e3
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD9c720895-f7a4-4e74-b5f2-a63ecf54887e3
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY9c720895-f7a4-4e74-b5f2-a63ecf54887e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2626-1530022626013 mL in 1 BOTTLE, DROPPER (53002-2626-1) 3 ml2019-06-010000-00-00NoNoCurrent