sitagliptin and metformin hydrochloride

Generic: sitagliptin and metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name sitagliptin and metformin hydrochloride
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 70710-2036
Product ID 70710-2036_8898638c-e4b3-4fdf-91e6-d39156e5ace9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA216778
Listing Expiration 2026-12-31
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 707102036
Hyphenated Format 70710-2036

Supplemental Identifiers

RxCUI
1243827 1243842 1243846
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 sitagliptin and metformin hydrochloride (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 (70710-2036-6)
source: ndc

Packages (1)

70710-2036-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-2036-6)

Ingredients (2)

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

Linked Drug Pages (1)

Sitagliptin and Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8898638c-e4b3-4fdf-91e6-d39156e5ace9", "openfda": {"nui": ["N0000175913", "N0000175912"], "unii": ["QFP0P1DV7Z", "786Z46389E"], "rxcui": ["1243827", "1243842", "1243846"], "spl_set_id": ["d3a728a0-decb-4340-8ee4-c5e27c13eb19"], "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 (70710-2036-6)", "package_ndc": "70710-2036-6", "marketing_start_date": "20241031"}], "brand_name": "Sitagliptin and Metformin Hydrochloride", "product_id": "70710-2036_8898638c-e4b3-4fdf-91e6-d39156e5ace9", "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": "70710-2036", "generic_name": "sitagliptin and metformin hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sitagliptin and Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}, {"name": "SITAGLIPTIN", "strength": "50 mg/1"}], "application_number": "NDA216778", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20241031", "listing_expiration_date": "20261231"}