COPIKTRA

Product NDC
73116-115
11-digit product format
731160115
Labeler code
73116
Product ID
73116-115_b2586d9d-9395-46d3-a0ff-d64c0ecb8e21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
duvelisib
Dosage form
CAPSULE
Route
ORAL
Labeler
Secura Bio, Inc.
Application
NDA211155
Marketing category
NDA
Marketing start
2018-09-25
Marketing end
0000-00-00
Substance
DUVELISIB
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73116-115-017311601150156 CAPSULE in 1 BOTTLE (73116-115-01) 56 capsule2018-09-250000-00-00NoNoCurrent
73116-115-02731160115022 PACKAGE in 1 CARTON (73116-115-02) > 28 BLISTER PACK in 1 PACKAGE (73116-115-03) > 1 CAPSULE in 1 BLISTER PACK2 package2018-09-250000-00-00NoNoCurrent