Solaraze

Product NDC
10337-803
11-digit product format
103370803
Labeler code
10337
Product ID
10337-803_1b521631-02df-447f-bfcc-1556606b652e
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
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
10337-803-01GM - Gram10337-803a534fb4b-821a-4f92-b4d6-90ef2e2cdbc812012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10337-803-01103370803011 TUBE in 1 CARTON (10337-803-01) > 100 g in 1 TUBE1 tube2000-10-160000-00-00NoNoCurrent
10337-803-08103370803082 g in 1 TUBE (10337-803-08) 2 g2000-10-160000-00-00NoNoCurrent
10337-803-81103370803811 TUBE in 1 CARTON (10337-803-81) > 2 g in 1 TUBE1 tube2000-10-160000-00-00NoNoCurrent
10337-803-97103370803971 TUBE in 1 CARTON (10337-803-97) > 5 g in 1 TUBE1 tube2000-10-160000-00-00NoNoCurrent
10337-803-99103370803995 g in 1 TUBE (10337-803-99) 5 g2000-10-160000-00-00NoNoCurrent