glimepiride

Generic: glimepiride

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 4 mg/1

Manufacturer
Direct_rx

Identifiers & Regulatory

Product NDC 72189-585
Product ID 72189-585_230949fd-563f-8dbf-e063-6394a90ab9b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202112
Listing Expiration 2026-12-31
Marketing Start 2024-09-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189585
Hyphenated Format 72189-585

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 ANDA202112 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (72189-585-90)
source: ndc

Packages (1)

72189-585-90 90 TABLET in 1 BOTTLE (72189-585-90)

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": "230949fd-563f-8dbf-e063-6394a90ab9b6", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199247"], "spl_set_id": ["230949fd-563e-8dbf-e063-6394a90ab9b6"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-585-90)", "package_ndc": "72189-585-90", "marketing_start_date": "20240926"}], "brand_name": "Glimepiride", "product_id": "72189-585_230949fd-563f-8dbf-e063-6394a90ab9b6", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "72189-585", "generic_name": "Glimepiride", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "4 mg/1"}], "application_number": "ANDA202112", "marketing_category": "ANDA", "marketing_start_date": "20240926", "listing_expiration_date": "20261231"}