glyburide

Generic: glyburide

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glyburide
Generic Name glyburide
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glyburide 2.5 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-657
Product ID 68382-657_1ff75368-1bfd-4173-b0aa-18eca2c97a4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206749
Listing Expiration 2026-12-31
Marketing Start 2016-06-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382657
Hyphenated Format 68382-657

Supplemental Identifiers

RxCUI
197737 310534 310537
UNII
SX6K58TVWC
NUI
N0000175608 M0020795

Packaging Origin

Original Packager
true

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 ANDA206749 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-657-01)
  • 500 TABLET in 1 BOTTLE (68382-657-05)
  • 30 TABLET in 1 BOTTLE (68382-657-06)
  • 1000 TABLET in 1 BOTTLE (68382-657-10)
  • 90 TABLET in 1 BOTTLE (68382-657-16)
  • 10 BLISTER PACK in 1 CARTON (68382-657-77) / 10 TABLET in 1 BLISTER PACK (68382-657-30)
source: ndc

Packages (6)

68382-657-01 100 TABLET in 1 BOTTLE (68382-657-01) 68382-657-05 500 TABLET in 1 BOTTLE (68382-657-05) 68382-657-06 30 TABLET in 1 BOTTLE (68382-657-06) 68382-657-10 1000 TABLET in 1 BOTTLE (68382-657-10) 68382-657-16 90 TABLET in 1 BOTTLE (68382-657-16) 68382-657-77 10 BLISTER PACK in 1 CARTON (68382-657-77) / 10 TABLET in 1 BLISTER PACK (68382-657-30)

Ingredients (1)

glyburide (2.5 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": "1ff75368-1bfd-4173-b0aa-18eca2c97a4f", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC"], "rxcui": ["197737", "310534", "310537"], "spl_set_id": ["87781ea8-62ec-483c-a4dd-8c965ce59485"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-657-01)", "package_ndc": "68382-657-01", "marketing_start_date": "20160602"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-657-05)", "package_ndc": "68382-657-05", "marketing_start_date": "20160602"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-657-06)", "package_ndc": "68382-657-06", "marketing_start_date": "20160602"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-657-10)", "package_ndc": "68382-657-10", "marketing_start_date": "20160602"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-657-16)", "package_ndc": "68382-657-16", "marketing_start_date": "20160602"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-657-77)  / 10 TABLET in 1 BLISTER PACK (68382-657-30)", "package_ndc": "68382-657-77", "marketing_start_date": "20160602"}], "brand_name": "glyburide", "product_id": "68382-657_1ff75368-1bfd-4173-b0aa-18eca2c97a4f", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "68382-657", "generic_name": "glyburide", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "glyburide", "active_ingredients": [{"name": "GLYBURIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA206749", "marketing_category": "ANDA", "marketing_start_date": "20160602", "listing_expiration_date": "20261231"}