DICLOFENAC SODIUM

Product NDC
0168-0803
11-digit product format
001680803
Labeler code
0168
Product ID
0168-0803_84bf3d93-cb17-4119-9fbe-0ee94841e29d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
NDA021005
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-05-06
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
0168-0803-01GM - Gram0168-0803181b13b5-5f48-4ec1-a0f8-16e297e04ae012013-12-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0803-01001680803011 TUBE in 1 CARTON (0168-0803-01) > 100 g in 1 TUBE1 tube2013-05-060000-00-00NoNoCurrent