glyburide

Generic: glyburide

Labeler: cadila pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glyburide
Generic Name glyburide
Labeler cadila pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glyburide 1.25 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-009
Product ID 71209-009_54461b9f-3232-47ce-9e73-a26ab1e44702
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203379
Listing Expiration 2026-12-31
Marketing Start 2014-04-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71209009
Hyphenated Format 71209-009

Supplemental Identifiers

RxCUI
197737 310534 310537
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 ANDA203379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (71209-009-05)
  • 1000 TABLET in 1 BOTTLE (71209-009-11)
source: ndc

Packages (2)

71209-009-05 100 TABLET in 1 BOTTLE (71209-009-05) 71209-009-11 1000 TABLET in 1 BOTTLE (71209-009-11)

Ingredients (1)

glyburide (1.25 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": "54461b9f-3232-47ce-9e73-a26ab1e44702", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["SX6K58TVWC"], "rxcui": ["197737", "310534", "310537"], "spl_set_id": ["ea7a055b-64f0-46bf-aa8e-4a2ef5c3c035"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (71209-009-05)", "package_ndc": "71209-009-05", "marketing_start_date": "20140426"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (71209-009-11)", "package_ndc": "71209-009-11", "marketing_start_date": "20140426"}], "brand_name": "Glyburide", "product_id": "71209-009_54461b9f-3232-47ce-9e73-a26ab1e44702", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "71209-009", "generic_name": "Glyburide", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glyburide", "active_ingredients": [{"name": "GLYBURIDE", "strength": "1.25 mg/1"}], "application_number": "ANDA203379", "marketing_category": "ANDA", "marketing_start_date": "20140426", "listing_expiration_date": "20261231"}