Package 0597-0295-78

Brand: synjardy xr

Generic: empagliflozin, metformin hydrochloride
NDC Package

Package Facts

Identity

Package NDC 0597-0295-78
Digits Only 0597029578
Product NDC 0597-0295
Description

90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0295-78)

Marketing

Marketing Status
Marketed Since 2016-12-10
Brand synjardy xr
Generic empagliflozin, metformin hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "09b6e275-e784-41d8-a75d-74a22f3e2eca", "openfda": {"nui": ["N0000187059", "N0000187058"], "unii": ["HDC1R2M35U", "786Z46389E"], "rxcui": ["1862685", "1862688", "1862691", "1862692", "1862695", "1862697", "1862700", "1862701"], "spl_set_id": ["8006ba29-ee3a-f852-a9bb-c8ec9b41cf66"], "pharm_class_epc": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (0597-0295-61)  / 7 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "0597-0295-61", "marketing_start_date": "20161210"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0295-78)", "package_ndc": "0597-0295-78", "marketing_start_date": "20161210"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0295-88)", "package_ndc": "0597-0295-88", "marketing_start_date": "20161210"}], "brand_name": "Synjardy XR", "product_id": "0597-0295_09b6e275-e784-41d8-a75d-74a22f3e2eca", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "0597-0295", "generic_name": "empagliflozin, metformin hydrochloride", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Synjardy", "brand_name_suffix": "XR", "active_ingredients": [{"name": "EMPAGLIFLOZIN", "strength": "25 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA208658", "marketing_category": "NDA", "marketing_start_date": "20161210", "listing_expiration_date": "20271231"}