glimepiride

Generic: glimepiride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 4 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-327
Product ID 68084-327_26cca05b-82f8-e191-e063-6394a90a56bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077091
Listing Expiration 2026-12-31
Marketing Start 2009-04-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084327
Hyphenated Format 68084-327

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 ANDA077091 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-327-01) / 1 TABLET in 1 BLISTER PACK (68084-327-11)
source: ndc

Packages (1)

68084-327-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-327-01) / 1 TABLET in 1 BLISTER PACK (68084-327-11)

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": "26cca05b-82f8-e191-e063-6394a90a56bd", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199245", "199246", "199247"], "spl_set_id": ["0003458f-352a-46fa-9d99-230daa76ae29"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-327-01)  / 1 TABLET in 1 BLISTER PACK (68084-327-11)", "package_ndc": "68084-327-01", "marketing_start_date": "20090422"}], "brand_name": "Glimepiride", "product_id": "68084-327_26cca05b-82f8-e191-e063-6394a90a56bd", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "68084-327", "generic_name": "Glimepiride", "labeler_name": "American Health Packaging", "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": "20090422", "listing_expiration_date": "20261231"}