Package 65862-080-05
Brand: glyburide and metformin hydrochloride
Generic: glyburide and metformin hydrochloridePackage Facts
Identity
Package NDC
65862-080-05
Digits Only
6586208005
Product NDC
65862-080
Description
500 TABLET, FILM COATED in 1 BOTTLE (65862-080-05)
Marketing
Marketing Status
Brand
glyburide and metformin hydrochloride
Generic
glyburide and metformin hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "70d68bf1-dadf-47e4-8070-2897ee4f7c8b", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC", "786Z46389E"], "rxcui": ["861743", "861748", "861753"], "spl_set_id": ["7010b662-8b34-49ce-8e5b-73dee0821a60"], "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, FILM COATED in 1 BOTTLE (65862-080-01)", "package_ndc": "65862-080-01", "marketing_start_date": "20071114"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-080-05)", "package_ndc": "65862-080-05", "marketing_start_date": "20071114"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-080-30)", "package_ndc": "65862-080-30", "marketing_start_date": "20071114"}], "brand_name": "Glyburide and Metformin Hydrochloride", "product_id": "65862-080_70d68bf1-dadf-47e4-8070-2897ee4f7c8b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "65862-080", "generic_name": "Glyburide and Metformin Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyburide and Metformin Hydrochloride", "active_ingredients": [{"name": "GLYBURIDE", "strength": "1.25 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA077870", "marketing_category": "ANDA", "marketing_start_date": "20071114", "listing_expiration_date": "20261231"}