sitagliptin

Generic: sitagliptin

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

Drug Facts

Product Profile

Brand Name sitagliptin
Generic Name sitagliptin
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sitagliptin 50 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 70710-1900
Product ID 70710-1900_c489d9fa-c7f0-473f-9f7b-77086e137e8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA211566
Listing Expiration 2026-12-31
Marketing Start 2023-11-30

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 707101900
Hyphenated Format 70710-1900

Supplemental Identifiers

RxCUI
665033 665038 665042
UPC
0370710190095
UNII
QFP0P1DV7Z
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 (source: ndc)
Generic Name sitagliptin (source: ndc)
Application Number NDA211566 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70710-1900-3)
  • 90 TABLET in 1 BOTTLE (70710-1900-9)
source: ndc

Packages (2)

70710-1900-3 30 TABLET in 1 BOTTLE (70710-1900-3) 70710-1900-9 90 TABLET in 1 BOTTLE (70710-1900-9)

Ingredients (1)

sitagliptin (50 mg/1)

Linked Drug Pages (1)

Sitagliptin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c489d9fa-c7f0-473f-9f7b-77086e137e8f", "openfda": {"nui": ["N0000175913", "N0000175912"], "upc": ["0370710190095"], "unii": ["QFP0P1DV7Z"], "rxcui": ["665033", "665038", "665042"], "spl_set_id": ["6a970e80-b753-48fa-9fff-87e7a5044982"], "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": "30 TABLET in 1 BOTTLE (70710-1900-3)", "package_ndc": "70710-1900-3", "marketing_start_date": "20231130"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70710-1900-9)", "package_ndc": "70710-1900-9", "marketing_start_date": "20231130"}], "brand_name": "Sitagliptin", "product_id": "70710-1900_c489d9fa-c7f0-473f-9f7b-77086e137e8f", "dosage_form": "TABLET", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "70710-1900", "generic_name": "Sitagliptin", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sitagliptin", "active_ingredients": [{"name": "SITAGLIPTIN", "strength": "50 mg/1"}], "application_number": "NDA211566", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20231130", "listing_expiration_date": "20261231"}