glyburide-metformin hydrochloride

Generic: glyburide-metformin hydrochloride

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glyburide-metformin hydrochloride
Generic Name glyburide-metformin hydrochloride
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glyburide 5 mg/1, metformin hydrochloride 500 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3950
Product ID 68071-3950_486febc2-9999-d6bb-e063-6294a90a9a1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079009
Listing Expiration 2027-12-31
Marketing Start 2024-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713950
Hyphenated Format 68071-3950

Supplemental Identifiers

RxCUI
861753
UPC
0368071395037
UNII
SX6K58TVWC 786Z46389E
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 glyburide-metformin hydrochloride (source: ndc)
Generic Name glyburide-metformin hydrochloride (source: ndc)
Application Number ANDA079009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68071-3950-3)
source: ndc

Packages (1)

68071-3950-3 30 TABLET in 1 BOTTLE (68071-3950-3)

Ingredients (2)

glyburide (5 mg/1) metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

glyburide-metformin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "486febc2-9999-d6bb-e063-6294a90a9a1e", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0368071395037"], "unii": ["SX6K58TVWC", "786Z46389E"], "rxcui": ["861753"], "spl_set_id": ["486fec17-ff83-3bab-e063-6394a90a5ef0"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-3950-3)", "package_ndc": "68071-3950-3", "marketing_start_date": "20260115"}], "brand_name": "glyburide-metformin hydrochloride", "product_id": "68071-3950_486febc2-9999-d6bb-e063-6294a90a9a1e", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "68071-3950", "generic_name": "glyburide-metformin hydrochloride", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "glyburide-metformin hydrochloride", "active_ingredients": [{"name": "GLYBURIDE", "strength": "5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA079009", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20271231"}