Zorvolex

Product NDC
69344-203
11-digit product format
693440203
Labeler code
69344
Product ID
69344-203_f5e319f9-9eeb-4bc5-9e53-985549d08d44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac
Dosage form
CAPSULE
Route
ORAL
Labeler
Zyla Life Sciences US Inc.
Application
NDA204592
Marketing category
NDA
Marketing start
2019-02-04
Marketing end
0000-00-00
Substance
DICLOFENAC
Active strength
18 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69344-203-29EA - Each69344-20370a32416-5d6d-4ddc-a133-453c70d878fd12019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69344-203-296934402032990 CAPSULE in 1 BOTTLE (69344-203-29) 90 capsule2019-02-040000-00-00NoNoCurrent