Trifluridine

Product NDC
50383-955
11-digit product format
503830955
Labeler code
50383
Product ID
50383-955_74748501-4565-4eab-833f-41c7e695c23a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trifluridine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Hi-Tech Pharmacal Co., Inc.
Application
ANDA205438
Marketing category
ANDA
Marketing start
2017-07-28
Marketing end
0000-00-00
Substance
TRIFLURIDINE
Active strength
10 mg/mL
Pharmacologic classes
Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC],Nucleoside Metabolic Inhibitor [EPC],Nucleic Acid Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-955-072022-05-27C16284748780-1d6a99b39-6377-a426-e053-dadaa90af4c20e451c1b-28a7-4f63-9aa5-6a70626d72f1
50383-955-072022-01-28C16284748780-1d6a99b39-6377-a426-e053-dadaa90af4c20e451c1b-28a7-4f63-9aa5-6a70626d72f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50383-955-07503830955071 BOTTLE, DROPPER in 1 CARTON (50383-955-07) > 7.5 mL in 1 BOTTLE, DROPPER2017-07-280000-00-00NoNoCurrent