glimepiride

Generic: glimepiride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 4 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2409
Product ID 71335-2409_5f8f3cde-9b59-4f0a-8363-2a645e3b904d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202112
Listing Expiration 2026-12-31
Marketing Start 2023-07-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713352409
Hyphenated Format 71335-2409

Supplemental Identifiers

RxCUI
199247
UNII
6KY687524K
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 glimepiride (source: ndc)
Generic Name glimepiride (source: ndc)
Application Number ANDA202112 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71335-2409-1)
  • 60 TABLET in 1 BOTTLE (71335-2409-2)
  • 90 TABLET in 1 BOTTLE (71335-2409-3)
  • 180 TABLET in 1 BOTTLE (71335-2409-4)
  • 100 TABLET in 1 BOTTLE (71335-2409-5)
source: ndc

Packages (5)

71335-2409-1 30 TABLET in 1 BOTTLE (71335-2409-1) 71335-2409-2 60 TABLET in 1 BOTTLE (71335-2409-2) 71335-2409-3 90 TABLET in 1 BOTTLE (71335-2409-3) 71335-2409-4 180 TABLET in 1 BOTTLE (71335-2409-4) 71335-2409-5 100 TABLET in 1 BOTTLE (71335-2409-5)

Ingredients (1)

glimepiride (4 mg/1)

Linked Drug Pages (1)

Glimepiride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5f8f3cde-9b59-4f0a-8363-2a645e3b904d", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199247"], "spl_set_id": ["0b12d4ab-fa0c-44d5-888c-265dbb661561"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-2409-1)", "package_ndc": "71335-2409-1", "marketing_start_date": "20240611"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-2409-2)", "package_ndc": "71335-2409-2", "marketing_start_date": "20240611"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-2409-3)", "package_ndc": "71335-2409-3", "marketing_start_date": "20240611"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71335-2409-4)", "package_ndc": "71335-2409-4", "marketing_start_date": "20240611"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (71335-2409-5)", "package_ndc": "71335-2409-5", "marketing_start_date": "20240611"}], "brand_name": "Glimepiride", "product_id": "71335-2409_5f8f3cde-9b59-4f0a-8363-2a645e3b904d", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "71335-2409", "generic_name": "Glimepiride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "4 mg/1"}], "application_number": "ANDA202112", "marketing_category": "ANDA", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}