glimepiride

Generic: glimepiride

Labeler: ncs healthcare of ky, inc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler ncs healthcare of ky, inc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 2 mg/1

Manufacturer
NCS HealthCare of KY, Inc dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8333
Product ID 0615-8333_18f8ad9b-20d5-47ea-ad3a-9b2a7e3a4dd8
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 06158333
Hyphenated Format 0615-8333

Supplemental Identifiers

RxCUI
199245 199246 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 ANDA091220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (0615-8333-39)
source: ndc

Packages (1)

0615-8333-39 30 TABLET in 1 BLISTER PACK (0615-8333-39)

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": "18f8ad9b-20d5-47ea-ad3a-9b2a7e3a4dd8", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199245", "199246", "199247"], "spl_set_id": ["669a67c2-2f97-4b7e-8bba-83a015e0fa94"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["NCS HealthCare of KY, Inc dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8333-39)", "package_ndc": "0615-8333-39", "marketing_start_date": "20200413"}], "brand_name": "Glimepiride", "product_id": "0615-8333_18f8ad9b-20d5-47ea-ad3a-9b2a7e3a4dd8", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "0615-8333", "generic_name": "Glimepiride", "labeler_name": "NCS HealthCare of KY, Inc dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "2 mg/1"}], "application_number": "ANDA091220", "marketing_category": "ANDA", "marketing_start_date": "20130613", "listing_expiration_date": "20261231"}