Solaraze

Product NDC
10337-844
11-digit product format
103370844
Labeler code
10337
Product ID
10337-844_e4157a10-c41a-4e10-b298-fe5bb3ee52df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
PharmaDerm a division of Fougera Pharmaceuticals Inc.
Application
NDA021005
Marketing category
NDA
Marketing start
2000-10-16
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
30 mg/g
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10337-844-01103370844011 TUBE in 1 CARTON (10337-844-01) > 100 g in 1 TUBE1 tube2000-10-160000-00-00NoNoCurrent