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 3 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-8035
Product ID 0093-8035_d734cd0e-df7b-40a2-a511-fc04308a764d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074686
Marketing Start 1999-05-11
Marketing End 2027-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00938035
Hyphenated Format 0093-8035

Supplemental Identifiers

RxCUI
310536 310539 314000
UPC
0300938034017 0300938035014 0300938036011
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 ANDA074686 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0093-8035-01)
  • 500 TABLET in 1 BOTTLE (0093-8035-05)
source: ndc

Packages (2)

0093-8035-01 100 TABLET in 1 BOTTLE (0093-8035-01) 0093-8035-05 500 TABLET in 1 BOTTLE (0093-8035-05)

Ingredients (1)

glyburide (3 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": "d734cd0e-df7b-40a2-a511-fc04308a764d", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0300938034017", "0300938035014", "0300938036011"], "unii": ["SX6K58TVWC"], "rxcui": ["310536", "310539", "314000"], "spl_set_id": ["e84c0dfc-a4e9-4c89-b6ea-45732eb412f5"], "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 (0093-8035-01)", "package_ndc": "0093-8035-01", "marketing_end_date": "20270131", "marketing_start_date": "19990511"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0093-8035-05)", "package_ndc": "0093-8035-05", "marketing_end_date": "20270131", "marketing_start_date": "19990511"}], "brand_name": "Glyburide", "product_id": "0093-8035_d734cd0e-df7b-40a2-a511-fc04308a764d", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "0093-8035", "generic_name": "Glyburide", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyburide", "active_ingredients": [{"name": "GLYBURIDE", "strength": "3 mg/1"}], "application_number": "ANDA074686", "marketing_category": "ANDA", "marketing_end_date": "20270131", "marketing_start_date": "19990511"}