glimepiride

Generic: glimepiride

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 2 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-042
Product ID 82868-042_46dcab92-b42f-b3f1-e063-6394a90a17c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202759
Listing Expiration 2026-12-31
Marketing Start 2024-01-26

Pharmacologic Class

Established (EPC)
sulfonylurea [epc]
Chemical Structure
sulfonylurea compounds [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82868042
Hyphenated Format 82868-042

Supplemental Identifiers

RxCUI
199246
UNII
6KY687524K
NUI
N0000175608 M0020795

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 glimepiride (source: ndc)
Generic Name glimepiride (source: ndc)
Application Number ANDA202759 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (82868-042-90)
source: ndc

Packages (1)

82868-042-90 90 TABLET in 1 BOTTLE, PLASTIC (82868-042-90)

Ingredients (1)

glimepiride (2 mg/1)

Linked Drug Pages (1)

Glimepiride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46dcab92-b42f-b3f1-e063-6394a90a17c3", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199246"], "spl_set_id": ["10a36c79-1b24-46b7-e063-6294a90a8dca"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (82868-042-90)", "package_ndc": "82868-042-90", "marketing_start_date": "20240126"}], "brand_name": "Glimepiride", "product_id": "82868-042_46dcab92-b42f-b3f1-e063-6394a90a17c3", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "82868-042", "generic_name": "Glimepiride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "2 mg/1"}], "application_number": "ANDA202759", "marketing_category": "ANDA", "marketing_start_date": "20240126", "listing_expiration_date": "20261231"}