zituvimet

Generic: sitagliptin and metformin hydrochloride

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zituvimet
Generic Name sitagliptin and metformin hydrochloride
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1, sitagliptin 50 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1860
Product ID 70771-1860_3bf9383a-afe0-4989-b952-50c995bd3fa5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216743
Listing Expiration 2026-12-31
Marketing Start 2024-03-14

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 707711860
Hyphenated Format 70771-1860

Supplemental Identifiers

RxCUI
861769 861819 2677162 2677164
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 (source: ndc)
Generic Name sitagliptin and metformin hydrochloride (source: ndc)
Application Number NDA216743 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (70771-1860-6)
  • 180 TABLET, FILM COATED in 1 BOTTLE (70771-1860-8)
source: ndc

Packages (2)

70771-1860-6 60 TABLET, FILM COATED in 1 BOTTLE (70771-1860-6) 70771-1860-8 180 TABLET, FILM COATED in 1 BOTTLE (70771-1860-8)

Ingredients (2)

metformin hydrochloride (1000 mg/1) sitagliptin (50 mg/1)

Linked Drug Pages (1)

ZITUVIMET ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3bf9383a-afe0-4989-b952-50c995bd3fa5", "openfda": {"nui": ["N0000175913", "N0000175912"], "unii": ["QFP0P1DV7Z", "786Z46389E"], "rxcui": ["861769", "861819", "2677162", "2677164"], "spl_set_id": ["0098dec4-f0e5-45d5-8aa4-5d0faf9ab142"], "pharm_class_epc": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (70771-1860-6)", "package_ndc": "70771-1860-6", "marketing_start_date": "20240314"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (70771-1860-8)", "package_ndc": "70771-1860-8", "marketing_start_date": "20240314"}], "brand_name": "ZITUVIMET", "product_id": "70771-1860_3bf9383a-afe0-4989-b952-50c995bd3fa5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "70771-1860", "generic_name": "Sitagliptin and Metformin Hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZITUVIMET", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}, {"name": "SITAGLIPTIN", "strength": "50 mg/1"}], "application_number": "NDA216743", "marketing_category": "NDA", "marketing_start_date": "20240314", "listing_expiration_date": "20261231"}