linagliptin and metformin hydrochloride (72205-407)

Drug Facts

Product Profile

Brand Name linagliptin and metformin hydrochloride

Generic Name linagliptin and metformin hydrochloride

Labeler novadoz pharmaceuticals llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

linagliptin 2.5 mg/1, metformin hydrochloride 500 mg/1

Manufacturer

Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-407

Product ID 72205-407_5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208459

Listing Expiration 2026-12-31

Marketing Start 2025-11-03

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 72205407

Hyphenated Format 72205-407

Supplemental Identifiers

RxCUI

1243020 1243027 1243034

UPC

0372205408029 0372205407015 0372205409019 0372205407022 0372205409026 0372205408012

UNII

3X29ZEJ4R2 786Z46389E

NUI

N0000175912 N0000175913

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 linagliptin and metformin hydrochloride (source: ndc)

Generic Name linagliptin and metformin hydrochloride (source: ndc)

Application Number ANDA208459 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

2.5 mg/1
500 mg/1

source: ndc

Packaging

60 TABLET, FILM COATED in 1 BOTTLE (72205-407-01)
180 TABLET, FILM COATED in 1 BOTTLE (72205-407-02)

source: ndc

Packages (2)

72205-407-01 60 TABLET, FILM COATED in 1 BOTTLE (72205-407-01) 72205-407-02 180 TABLET, FILM COATED in 1 BOTTLE (72205-407-02)

Ingredients (2)

linagliptin (2.5 mg/1) metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Linagliptin and metformin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb", "openfda": {"nui": ["N0000175912", "N0000175913"], "upc": ["0372205408029", "0372205407015", "0372205409019", "0372205407022", "0372205409026", "0372205408012"], "unii": ["3X29ZEJ4R2", "786Z46389E"], "rxcui": ["1243020", "1243027", "1243034"], "spl_set_id": ["5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb"], "pharm_class_epc": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (72205-407-01)", "package_ndc": "72205-407-01", "marketing_start_date": "20251104"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (72205-407-02)", "package_ndc": "72205-407-02", "marketing_start_date": "20251104"}], "brand_name": "Linagliptin and metformin hydrochloride", "product_id": "72205-407_5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "72205-407", "generic_name": "Linagliptin and metformin hydrochloride", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linagliptin and metformin hydrochloride", "active_ingredients": [{"name": "LINAGLIPTIN", "strength": "2.5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA208459", "marketing_category": "ANDA", "marketing_start_date": "20251103", "listing_expiration_date": "20261231"}