Package 68788-8766-3

{"route": ["ORAL"], "spl_id": "136bb61b-a256-476b-8eb7-0efad90be2c4", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["R6DXU4WAY9", "57Y76R9ATQ"], "rxcui": ["994008"], "spl_set_id": ["b295a90e-320f-4414-b80a-d11f06c00c96"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8766-3)", "package_ndc": "68788-8766-3", "marketing_start_date": "20241108"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8766-6)", "package_ndc": "68788-8766-6", "marketing_start_date": "20241108"}], "brand_name": "Naproxen and esomeprazole magnesium", "product_id": "68788-8766_136bb61b-a256-476b-8eb7-0efad90be2c4", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68788-8766", "generic_name": "Naproxen and esomeprazole magnesium", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen and esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE", "strength": "20 mg/1"}, {"name": "NAPROXEN", "strength": "500 mg/1"}], "application_number": "ANDA213699", "marketing_category": "ANDA", "marketing_start_date": "20241108", "listing_expiration_date": "20271231"}