Home NDC 63629-4970 Diclofenac Sodium and Misoprostol
Product NDC 63629-4970
11-digit product format 636294970
Labeler code 63629
Product ID 63629-4970_8c7a84ca-915f-4e71-9bb0-3ca70a5ae517
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium and Misoprostol
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA201089
Marketing category ANDA
Marketing start 2012-11-01
Marketing end 0000-00-00
Substance DICLOFENAC SODIUM; MISOPROSTOL
Active strength 75 mg/1; ug/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-4970-1 63629497001 20 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4970-1) 2013-04-05 0000-00-00 No No Current 63629-4970-2 63629497002 14 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4970-2) 2013-09-10 0000-00-00 No No Current 63629-4970-3 63629497003 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4970-3) 2014-10-27 0000-00-00 No No Current 63629-4970-4 63629497004 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4970-4) 2021-12-22 0000-00-00 No No Current 63629-4970-5 63629497005 10 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4970-5) 2021-12-22 0000-00-00 No No Current