glyburide

Generic: glyburide

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glyburide
Generic Name glyburide
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glyburide 5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-150
Product ID 82804-150_7378c94f-e2fc-4990-977b-9087a3789e91
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 82804150
Hyphenated Format 82804-150

Supplemental Identifiers

RxCUI
310537
UPC
0382804150007
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 ANDA074388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (82804-150-00)
  • 30 TABLET in 1 BOTTLE (82804-150-30)
source: ndc

Packages (2)

82804-150-00 100 TABLET in 1 BOTTLE (82804-150-00) 82804-150-30 30 TABLET in 1 BOTTLE (82804-150-30)

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": "7378c94f-e2fc-4990-977b-9087a3789e91", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0382804150007"], "unii": ["SX6K58TVWC"], "rxcui": ["310537"], "spl_set_id": ["6f65131c-90df-45ab-95fb-c36f411c6fbe"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (82804-150-00)", "package_ndc": "82804-150-00", "marketing_start_date": "20240924"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-150-30)", "package_ndc": "82804-150-30", "marketing_start_date": "20250718"}], "brand_name": "Glyburide", "product_id": "82804-150_7378c94f-e2fc-4990-977b-9087a3789e91", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "82804-150", "generic_name": "Glyburide", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyburide", "active_ingredients": [{"name": "GLYBURIDE", "strength": "5 mg/1"}], "application_number": "ANDA074388", "marketing_category": "ANDA", "marketing_start_date": "19950830", "listing_expiration_date": "20261231"}