glyburide

Generic: glyburide

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glyburide
Generic Name glyburide
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glyburide 2.5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3504
Product ID 70518-3504_3aae409d-723d-57ca-e063-6394a90ae78b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203379
Listing Expiration 2026-12-31
Marketing Start 2022-08-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183504
Hyphenated Format 70518-3504

Supplemental Identifiers

RxCUI
310534
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 ANDA203379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-3504-1)
source: ndc

Packages (1)

70518-3504-1 30 TABLET in 1 BLISTER PACK (70518-3504-1)

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": "3aae409d-723d-57ca-e063-6394a90ae78b", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC"], "rxcui": ["310534"], "spl_set_id": ["e23b9a3b-0184-4d1c-8e2c-668697a6da87"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3504-1)", "package_ndc": "70518-3504-1", "marketing_start_date": "20240212"}], "brand_name": "Glyburide", "product_id": "70518-3504_3aae409d-723d-57ca-e063-6394a90ae78b", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "70518-3504", "generic_name": "Glyburide", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyburide", "active_ingredients": [{"name": "GLYBURIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA203379", "marketing_category": "ANDA", "marketing_start_date": "20220831", "listing_expiration_date": "20261231"}