glyburide

Generic: glyburide

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

Drug Facts

Product Profile

Brand Name glyburide
Generic Name glyburide
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glyburide 5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8508
Product ID 68788-8508_7f6a864b-09ad-45b5-9132-777aeb4f1107
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203379
Listing Expiration 2026-12-31
Marketing Start 2023-08-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888508
Hyphenated Format 68788-8508

Supplemental Identifiers

RxCUI
310537
UNII
SX6K58TVWC
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 (source: ndc)
Generic Name glyburide (source: ndc)
Application Number ANDA203379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8508-1)
  • 30 TABLET in 1 BOTTLE (68788-8508-3)
  • 60 TABLET in 1 BOTTLE (68788-8508-6)
  • 90 TABLET in 1 BOTTLE (68788-8508-9)
source: ndc

Packages (4)

68788-8508-1 100 TABLET in 1 BOTTLE (68788-8508-1) 68788-8508-3 30 TABLET in 1 BOTTLE (68788-8508-3) 68788-8508-6 60 TABLET in 1 BOTTLE (68788-8508-6) 68788-8508-9 90 TABLET in 1 BOTTLE (68788-8508-9)

Ingredients (1)

glyburide (5 mg/1)

Linked Drug Pages (1)

Glyburide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7f6a864b-09ad-45b5-9132-777aeb4f1107", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC"], "rxcui": ["310537"], "spl_set_id": ["cf21c8c0-7247-4d5b-97f8-ae4016144642"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8508-1)", "package_ndc": "68788-8508-1", "marketing_start_date": "20230816"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8508-3)", "package_ndc": "68788-8508-3", "marketing_start_date": "20230816"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8508-6)", "package_ndc": "68788-8508-6", "marketing_start_date": "20230816"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8508-9)", "package_ndc": "68788-8508-9", "marketing_start_date": "20230816"}], "brand_name": "Glyburide", "product_id": "68788-8508_7f6a864b-09ad-45b5-9132-777aeb4f1107", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "68788-8508", "generic_name": "Glyburide", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyburide", "active_ingredients": [{"name": "GLYBURIDE", "strength": "5 mg/1"}], "application_number": "ANDA203379", "marketing_category": "ANDA", "marketing_start_date": "20230816", "listing_expiration_date": "20261231"}