glyburide and metformin hydrochloride

Generic: glyburide and metformin hydrochloride

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

Drug Facts

Product Profile

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

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

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4718
Product ID 68071-4718_1ab9df7f-6510-2ace-e063-6394a90a3bde
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077870
Listing Expiration 2026-12-31
Marketing Start 2007-11-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680714718
Hyphenated Format 68071-4718

Supplemental Identifiers

RxCUI
861753
UPC
0368071471830
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 and metformin hydrochloride (source: ndc)
Generic Name glyburide and metformin hydrochloride (source: ndc)
Application Number ANDA077870 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68071-4718-3)
source: ndc

Packages (1)

68071-4718-3 30 TABLET, FILM COATED in 1 BOTTLE (68071-4718-3)

Ingredients (2)

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

Linked Drug Pages (1)

Glyburide and Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1ab9df7f-6510-2ace-e063-6394a90a3bde", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0368071471830"], "unii": ["SX6K58TVWC", "786Z46389E"], "rxcui": ["861753"], "spl_set_id": ["7facb5ac-c1d5-43b4-e053-2991aa0a2a7b"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-4718-3)", "package_ndc": "68071-4718-3", "marketing_start_date": "20190117"}], "brand_name": "Glyburide and Metformin Hydrochloride", "product_id": "68071-4718_1ab9df7f-6510-2ace-e063-6394a90a3bde", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "68071-4718", "generic_name": "Glyburide and Metformin Hydrochloride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyburide and Metformin Hydrochloride", "active_ingredients": [{"name": "GLYBURIDE", "strength": "5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA077870", "marketing_category": "ANDA", "marketing_start_date": "20071114", "listing_expiration_date": "20261231"}