glyburide

Generic: glyburide

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glyburide
Generic Name glyburide
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glyburide 5 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-585
Product ID 62135-585_458a6ce1-673d-85c7-e063-6294a90a3577
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090937
Listing Expiration 2026-12-31
Marketing Start 2010-10-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135585
Hyphenated Format 62135-585

Supplemental Identifiers

RxCUI
197737 310534 310537
UPC
0362135585907 0362135584306 0362135583309
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 ANDA090937 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (62135-585-90)
source: ndc

Packages (1)

62135-585-90 90 TABLET in 1 BOTTLE (62135-585-90)

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": "458a6ce1-673d-85c7-e063-6294a90a3577", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0362135585907", "0362135584306", "0362135583309"], "unii": ["SX6K58TVWC"], "rxcui": ["197737", "310534", "310537"], "spl_set_id": ["7e661288-2d24-4403-86a1-754afa1d04ff"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-585-90)", "package_ndc": "62135-585-90", "marketing_start_date": "20230509"}], "brand_name": "GLYBURIDE", "product_id": "62135-585_458a6ce1-673d-85c7-e063-6294a90a3577", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "62135-585", "generic_name": "GLYBURIDE", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLYBURIDE", "active_ingredients": [{"name": "GLYBURIDE", "strength": "5 mg/1"}], "application_number": "ANDA090937", "marketing_category": "ANDA", "marketing_start_date": "20101005", "listing_expiration_date": "20261231"}