Home NDC 68788-7103 Diclofenac Sodium and Misoprostol
Product NDC 68788-7103
11-digit product format 687887103
Labeler code 68788
Product ID 68788-7103_817573a2-cf66-4d70-9946-d1022ca01759
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium and Misoprostol
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA203995
Marketing category ANDA
Marketing start 2018-03-13
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 2022-12-31
Current FDA listing Historical FDA.report record FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68788-7103-3 68788710303 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-7103-3) 2018-03-13 0000-00-00 No No Current 68788-7103-6 68788710306 6 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-7103-6) 2018-03-13 0000-00-00 No No Current