DICLOFENAC SODIUM

Product NDC
0168-0844
11-digit product format
001680844
Labeler code
0168
Product ID
0168-0844_e0309be9-5dd6-4285-aa7a-e00e7bd4b59d
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
0168-0844-01GM - Gram0168-08447f8b1858-4f42-4fca-935b-429d0ed4643812016-03-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0844-01001680844011 TUBE in 1 CARTON (0168-0844-01) > 100 g in 1 TUBE1 tube2016-02-240000-00-00NoNoCurrent