zituvimet xr

Generic: sitagliptin and metformin hydrochloride

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zituvimet xr
Generic Name sitagliptin and metformin hydrochloride
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1, sitagliptin 50 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1804
Product ID 70710-1804_506adfe0-80b4-4a62-9b2c-39bb23b04254
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216778
Listing Expiration 2027-12-31
Marketing Start 2024-10-31

Pharmacologic Class

Established (EPC)
dipeptidyl peptidase 4 inhibitor [epc]
Mechanism of Action
dipeptidyl peptidase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101804
Hyphenated Format 70710-1804

Supplemental Identifiers

RxCUI
1243827 1243842 1243846 2696282 2696284 2696287
UNII
QFP0P1DV7Z 786Z46389E
NUI
N0000175913 N0000175912

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 zituvimet xr (source: ndc)
Generic Name sitagliptin and metformin hydrochloride (source: ndc)
Application Number NDA216778 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1804-6)
source: ndc

Packages (1)

70710-1804-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1804-6)

Ingredients (2)

metformin hydrochloride (500 mg/1) sitagliptin (50 mg/1)

Linked Drug Pages (1)

ZITUVIMET XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "506adfe0-80b4-4a62-9b2c-39bb23b04254", "openfda": {"nui": ["N0000175913", "N0000175912"], "unii": ["QFP0P1DV7Z", "786Z46389E"], "rxcui": ["1243827", "1243842", "1243846", "2696282", "2696284", "2696287"], "spl_set_id": ["2f635b36-e86a-4e53-8eaf-589917b5f342"], "pharm_class_epc": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1804-6)", "package_ndc": "70710-1804-6", "marketing_start_date": "20241031"}], "brand_name": "ZITUVIMET XR", "product_id": "70710-1804_506adfe0-80b4-4a62-9b2c-39bb23b04254", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "70710-1804", "generic_name": "sitagliptin and metformin hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZITUVIMET XR", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}, {"name": "SITAGLIPTIN", "strength": "50 mg/1"}], "application_number": "NDA216778", "marketing_category": "NDA", "marketing_start_date": "20241031", "listing_expiration_date": "20271231"}