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 4 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-489
Product ID 51655-489_490f74f0-91bc-3e85-e063-6394a90a9ef9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077091
Listing Expiration 2027-12-31
Marketing Start 2020-12-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655489
Hyphenated Format 51655-489

Supplemental Identifiers

RxCUI
199247
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 ANDA077091 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (51655-489-26)
  • 30 TABLET in 1 BOTTLE, PLASTIC (51655-489-52)
source: ndc

Packages (2)

51655-489-26 90 TABLET in 1 BOTTLE, PLASTIC (51655-489-26) 51655-489-52 30 TABLET in 1 BOTTLE, PLASTIC (51655-489-52)

Ingredients (1)

glimepiride (4 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": "490f74f0-91bc-3e85-e063-6394a90a9ef9", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199247"], "spl_set_id": ["f3184cd3-df99-db32-e053-2995a90aa573"], "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 (51655-489-26)", "package_ndc": "51655-489-26", "marketing_start_date": "20230227"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (51655-489-52)", "package_ndc": "51655-489-52", "marketing_start_date": "20201210"}], "brand_name": "Glimepiride", "product_id": "51655-489_490f74f0-91bc-3e85-e063-6394a90a9ef9", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "51655-489", "generic_name": "Glimepiride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "4 mg/1"}], "application_number": "ANDA077091", "marketing_category": "ANDA", "marketing_start_date": "20201210", "listing_expiration_date": "20271231"}