Package 0591-0397-60
Brand: diclofenac sodium and misoprostol
Generic: diclofenac sodium and misoprostolPackage Facts
Identity
Package NDC
0591-0397-60
Digits Only
0591039760
Product NDC
0591-0397
Description
60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-60)
Marketing
Marketing Status
Brand
diclofenac sodium and misoprostol
Generic
diclofenac sodium and misoprostol
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "03f24a4c-0fe7-446a-b64d-a7c6b12cae0f", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["857706", "1359105"], "spl_set_id": ["df8b8660-0c24-4848-8bea-c1b935090c66"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-19)", "package_ndc": "0591-0397-19", "marketing_start_date": "20121101"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-60)", "package_ndc": "0591-0397-60", "marketing_start_date": "20121101"}], "brand_name": "Diclofenac Sodium and Misoprostol", "product_id": "0591-0397_03f24a4c-0fe7-446a-b64d-a7c6b12cae0f", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "0591-0397", "generic_name": "Diclofenac Sodium and Misoprostol", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium and Misoprostol", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "50 mg/1"}, {"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA201089", "marketing_category": "ANDA", "marketing_start_date": "20121101", "listing_expiration_date": "20261231"}