Diclofenac sodium

Product NDC
55700-675
11-digit product format
557000675
Labeler code
55700
Product ID
55700-675_8b3227c6-bea9-4de9-9f8e-be6c1f1db4a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac
Dosage form
GEL
Route
TOPICAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA208077
Marketing category
ANDA
Marketing start
2018-08-31
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-675-00GM - Gram55700-67519cdf6a3-72ed-45ca-8678-6806867458bf12018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-675-00557000675001 TUBE in 1 CARTON (55700-675-00) > 100 g in 1 TUBE1 tube2018-08-310000-00-00NoNoCurrent