linagliptin

Generic: linagliptin

Labeler: sunshine lake pharma co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linagliptin
Generic Name linagliptin
Labeler sunshine lake pharma co., ltd.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

linagliptin 5 mg/1

Manufacturer
Sunshine Lake Pharma Co., Ltd.

Identifiers & Regulatory

Product NDC 48792-7865
Product ID 48792-7865_4865a926-1da4-15be-e063-6294a90a4b76
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208335
Listing Expiration 2027-12-31
Marketing Start 2026-01-01

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 487927865
Hyphenated Format 48792-7865

Supplemental Identifiers

RxCUI
1100702
UNII
3X29ZEJ4R2
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 (source: ndc)
Generic Name linagliptin (source: ndc)
Application Number ANDA208335 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (48792-7865-1)
source: ndc

Packages (1)

48792-7865-1 30 TABLET, FILM COATED in 1 BOTTLE (48792-7865-1)

Ingredients (1)

linagliptin (5 mg/1)

Linked Drug Pages (1)

linagliptin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4865a926-1da4-15be-e063-6294a90a4b76", "openfda": {"nui": ["N0000175912", "N0000175913"], "unii": ["3X29ZEJ4R2"], "rxcui": ["1100702"], "spl_set_id": ["cbdbd4b2-c07b-00e1-e053-2995a90a5fc9"], "pharm_class_epc": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "manufacturer_name": ["Sunshine Lake Pharma Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (48792-7865-1)", "package_ndc": "48792-7865-1", "marketing_start_date": "20260101"}], "brand_name": "linagliptin", "product_id": "48792-7865_4865a926-1da4-15be-e063-6294a90a4b76", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "48792-7865", "generic_name": "linagliptin", "labeler_name": "Sunshine Lake Pharma Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "linagliptin", "active_ingredients": [{"name": "LINAGLIPTIN", "strength": "5 mg/1"}], "application_number": "ANDA208335", "marketing_category": "ANDA", "marketing_start_date": "20260101", "listing_expiration_date": "20271231"}