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 5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4035
Product ID 70518-4035_38516eee-640b-10f4-e063-6394a90a21ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203379
Listing Expiration 2026-12-31
Marketing Start 2024-03-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184035
Hyphenated Format 70518-4035

Supplemental Identifiers

RxCUI
310537
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
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-4035-0)
  • 360 TABLET in 1 BOTTLE, PLASTIC (70518-4035-1)
source: ndc

Packages (2)

70518-4035-0 30 TABLET in 1 BLISTER PACK (70518-4035-0) 70518-4035-1 360 TABLET in 1 BOTTLE, PLASTIC (70518-4035-1)

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": "38516eee-640b-10f4-e063-6394a90a21ec", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC"], "rxcui": ["310537"], "spl_set_id": ["524eec41-37ee-419a-b7a1-d23e888ae6ab"], "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 (70518-4035-0)", "package_ndc": "70518-4035-0", "marketing_start_date": "20240311"}, {"sample": false, "description": "360 TABLET in 1 BOTTLE, PLASTIC (70518-4035-1)", "package_ndc": "70518-4035-1", "marketing_start_date": "20250624"}], "brand_name": "Glyburide", "product_id": "70518-4035_38516eee-640b-10f4-e063-6394a90a21ec", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "70518-4035", "generic_name": "Glyburide", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyburide", "active_ingredients": [{"name": "GLYBURIDE", "strength": "5 mg/1"}], "application_number": "ANDA203379", "marketing_category": "ANDA", "marketing_start_date": "20240311", "listing_expiration_date": "20261231"}