Diclofenac Sodium

Product NDC
55700-588
11-digit product format
557000588
Labeler code
55700
Product ID
55700-588_c77e2e2a-cd25-4c91-b1e9-efb242083543
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA200936
Marketing category
ANDA
Marketing start
2018-03-02
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
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-588-00557000588001 TUBE in 1 CARTON (55700-588-00) > 100 g in 1 TUBE1 tube2018-03-020000-00-00NoNoCurrent