glimepiride

Generic: glimepiride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 4 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-581
Product ID 65862-581_f645f896-81d3-4773-91d5-54d04dedee04
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202759
Listing Expiration 2027-12-31
Marketing Start 2012-06-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862581
Hyphenated Format 65862-581

Supplemental Identifiers

RxCUI
199245 199246 199247
UNII
6KY687524K
NUI
N0000175608 M0020795

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

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65862-581-01)
  • 500 TABLET in 1 BOTTLE (65862-581-05)
  • 250 TABLET in 1 BOTTLE (65862-581-25)
  • 1000 TABLET in 1 BOTTLE (65862-581-99)
source: ndc

Packages (4)

65862-581-01 100 TABLET in 1 BOTTLE (65862-581-01) 65862-581-05 500 TABLET in 1 BOTTLE (65862-581-05) 65862-581-25 250 TABLET in 1 BOTTLE (65862-581-25) 65862-581-99 1000 TABLET in 1 BOTTLE (65862-581-99)

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": "f645f896-81d3-4773-91d5-54d04dedee04", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199245", "199246", "199247"], "spl_set_id": ["28eefc95-d92e-4555-b6c5-2933860b0610"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65862-581-01)", "package_ndc": "65862-581-01", "marketing_start_date": "20120629"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65862-581-05)", "package_ndc": "65862-581-05", "marketing_start_date": "20120629"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (65862-581-25)", "package_ndc": "65862-581-25", "marketing_start_date": "20120629"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-581-99)", "package_ndc": "65862-581-99", "marketing_start_date": "20120629"}], "brand_name": "Glimepiride", "product_id": "65862-581_f645f896-81d3-4773-91d5-54d04dedee04", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "65862-581", "generic_name": "Glimepiride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "4 mg/1"}], "application_number": "ANDA202759", "marketing_category": "ANDA", "marketing_start_date": "20120629", "listing_expiration_date": "20271231"}