glyburide

Generic: glyburide

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

Drug Facts

Product Profile

Brand Name glyburide
Generic Name glyburide
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glyburide 2.5 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-8343
Product ID 0093-8343_f4b5b433-1b6e-4af2-9d16-7194c2da041c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074388
Listing Expiration 2026-12-31
Marketing Start 1995-08-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00938343
Hyphenated Format 0093-8343

Supplemental Identifiers

RxCUI
197737 310534 310537
UPC
0300938343010 0300938344017 0300938342013
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 ANDA074388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0093-8343-01)
  • 500 TABLET in 1 BOTTLE (0093-8343-05)
  • 1000 TABLET in 1 BOTTLE (0093-8343-10)
  • 90 TABLET in 1 BOTTLE (0093-8343-98)
source: ndc

Packages (4)

0093-8343-01 100 TABLET in 1 BOTTLE (0093-8343-01) 0093-8343-05 500 TABLET in 1 BOTTLE (0093-8343-05) 0093-8343-10 1000 TABLET in 1 BOTTLE (0093-8343-10) 0093-8343-98 90 TABLET in 1 BOTTLE (0093-8343-98)

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": "f4b5b433-1b6e-4af2-9d16-7194c2da041c", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0300938343010", "0300938344017", "0300938342013"], "unii": ["SX6K58TVWC"], "rxcui": ["197737", "310534", "310537"], "spl_set_id": ["a56f100f-0f42-4188-81ab-04644b824040"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0093-8343-01)", "package_ndc": "0093-8343-01", "marketing_start_date": "19950830"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0093-8343-05)", "package_ndc": "0093-8343-05", "marketing_start_date": "19950830"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0093-8343-10)", "package_ndc": "0093-8343-10", "marketing_start_date": "19950830"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (0093-8343-98)", "package_ndc": "0093-8343-98", "marketing_start_date": "20100330"}], "brand_name": "Glyburide", "product_id": "0093-8343_f4b5b433-1b6e-4af2-9d16-7194c2da041c", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "0093-8343", "generic_name": "Glyburide", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyburide", "active_ingredients": [{"name": "GLYBURIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA074388", "marketing_category": "ANDA", "marketing_start_date": "19950830", "listing_expiration_date": "20261231"}