synjardy

Generic: empagliflozin and metformin hydrochloride

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name synjardy
Generic Name empagliflozin and metformin hydrochloride
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

empagliflozin 12.5 mg/1, metformin hydrochloride 500 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0180
Product ID 0597-0180_06cb5e7a-ca7a-474a-a968-b3ddc7af1c43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206111
Listing Expiration 2027-12-31
Marketing Start 2015-08-26

Pharmacologic Class

Established (EPC)
sodium-glucose cotransporter 2 inhibitor [epc]
Mechanism of Action
sodium-glucose transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970180
Hyphenated Format 0597-0180

Supplemental Identifiers

RxCUI
1664315 1664321 1664323 1664325 1664326 1664328 1665367 1665369
UNII
HDC1R2M35U 786Z46389E
NUI
N0000187059 N0000187058

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name synjardy (source: ndc)
Generic Name empagliflozin and metformin hydrochloride (source: ndc)
Application Number NDA206111 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 500 mg/1
source: ndc
Packaging
  • 180 TABLET in 1 BOTTLE (0597-0180-18)
  • 60 TABLET in 1 BOTTLE (0597-0180-60)
source: ndc

Packages (2)

0597-0180-18 180 TABLET in 1 BOTTLE (0597-0180-18) 0597-0180-60 60 TABLET in 1 BOTTLE (0597-0180-60)

Ingredients (2)

empagliflozin (12.5 mg/1) metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Synjardy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "06cb5e7a-ca7a-474a-a968-b3ddc7af1c43", "openfda": {"nui": ["N0000187059", "N0000187058"], "unii": ["HDC1R2M35U", "786Z46389E"], "rxcui": ["1664315", "1664321", "1664323", "1664325", "1664326", "1664328", "1665367", "1665369"], "spl_set_id": ["0fdd0255-0055-65f3-b2c0-db8fbb87beae"], "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": false, "description": "180 TABLET in 1 BOTTLE (0597-0180-18)", "package_ndc": "0597-0180-18", "marketing_start_date": "20150912"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (0597-0180-60)", "package_ndc": "0597-0180-60", "marketing_start_date": "20150912"}], "brand_name": "Synjardy", "product_id": "0597-0180_06cb5e7a-ca7a-474a-a968-b3ddc7af1c43", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "0597-0180", "generic_name": "empagliflozin and metformin hydrochloride", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Synjardy", "active_ingredients": [{"name": "EMPAGLIFLOZIN", "strength": "12.5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "NDA206111", "marketing_category": "NDA", "marketing_start_date": "20150826", "listing_expiration_date": "20271231"}