synjardy xr

Generic: empagliflozin, metformin hydrochloride

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

Drug Facts

Product Profile

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

empagliflozin 12.5 mg/1, metformin hydrochloride 1000 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0300
Product ID 0597-0300_09b6e275-e784-41d8-a75d-74a22f3e2eca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208658
Listing Expiration 2027-12-31
Marketing Start 2016-12-10

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 05970300
Hyphenated Format 0597-0300

Supplemental Identifiers

RxCUI
1862685 1862688 1862691 1862692 1862695 1862697 1862700 1862701
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 xr (source: ndc)
Generic Name empagliflozin, metformin hydrochloride (source: ndc)
Application Number NDA208658 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 1000 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0597-0300-20) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0300-45)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0300-93)
source: ndc

Packages (3)

0597-0300-20 1 BOTTLE in 1 CARTON (0597-0300-20) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE 0597-0300-45 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0300-45) 0597-0300-93 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0300-93)

Ingredients (2)

empagliflozin (12.5 mg/1) metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

Synjardy XR ndc-match (0.9)

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 (0597-0300-20)  / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "0597-0300-20", "marketing_start_date": "20161210"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0300-45)", "package_ndc": "0597-0300-45", "marketing_start_date": "20161210"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0300-93)", "package_ndc": "0597-0300-93", "marketing_start_date": "20161210"}], "brand_name": "Synjardy XR", "product_id": "0597-0300_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": "0597-0300", "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": "12.5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA208658", "marketing_category": "NDA", "marketing_start_date": "20161210", "listing_expiration_date": "20271231"}