glimepiride

Generic: glimepiride

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 6 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-104
Product ID 42571-104_34e9a6b6-450b-7d20-e063-6294a90ac831
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091220
Listing Expiration 2026-12-31
Marketing Start 2013-06-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571104
Hyphenated Format 42571-104

Supplemental Identifiers

RxCUI
153842 199245 199246 199247 1361493 1361495
UPC
0342571100018 0342571102012 0342571101015 0342571104016 0342571105013 0342571103019
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 ANDA091220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42571-104-01)
  • 500 TABLET in 1 BOTTLE (42571-104-05)
source: ndc

Packages (2)

42571-104-01 100 TABLET in 1 BOTTLE (42571-104-01) 42571-104-05 500 TABLET in 1 BOTTLE (42571-104-05)

Ingredients (1)

glimepiride (6 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": "34e9a6b6-450b-7d20-e063-6294a90ac831", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0342571100018", "0342571102012", "0342571101015", "0342571104016", "0342571105013", "0342571103019"], "unii": ["6KY687524K"], "rxcui": ["153842", "199245", "199246", "199247", "1361493", "1361495"], "spl_set_id": ["60e9397e-83b9-489e-9683-6f87e458bbaa"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42571-104-01)", "package_ndc": "42571-104-01", "marketing_start_date": "20130613"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (42571-104-05)", "package_ndc": "42571-104-05", "marketing_start_date": "20130613"}], "brand_name": "Glimepiride", "product_id": "42571-104_34e9a6b6-450b-7d20-e063-6294a90ac831", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "42571-104", "generic_name": "Glimepiride", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "6 mg/1"}], "application_number": "ANDA091220", "marketing_category": "ANDA", "marketing_start_date": "20130613", "listing_expiration_date": "20261231"}