Kerydin

Product NDC
10337-905
11-digit product format
103370905
Labeler code
10337
Product ID
10337-905_3d362b47-37c4-489d-91c6-a2b7ec99e207
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tavaborole
Dosage form
SOLUTION
Route
TOPICAL
Labeler
PharmaDerm, A division of Fougera Pharmaceuticals Inc.
Application
NDA204427
Marketing category
NDA
Marketing start
2014-07-07
Marketing end
0000-00-00
Substance
TAVABOROLE
Active strength
44 mg/mL
Pharmacologic classes
Oxaborole Antifungal [EPC],Protein Synthesis Inhibitors [MoA],Boron Compounds [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10337-905-10ML - Milliliter10337-9057eee8a46-535f-42be-80ad-4715973dcda012015-06-09
10337-905-44ML - Milliliter10337-905c4ebea05-d58e-4345-aab2-c4317f4230d012015-07-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10337-905-10103370905101 BOTTLE, WITH APPLICATOR in 1 CARTON (10337-905-10) > 10 mL in 1 BOTTLE, WITH APPLICATOR2014-07-070000-00-00NoNoCurrent
10337-905-44103370905441 BOTTLE, WITH APPLICATOR in 1 CARTON (10337-905-44) > 4 mL in 1 BOTTLE, WITH APPLICATOR2014-07-070000-00-00NoNoCurrent