glimepiride

Generic: glimepiride

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

Drug Facts

Product Profile

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

glimepiride 4 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4485
Product ID 70518-4485_42ed41d4-9928-5342-e063-6394a90af67e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202112
Listing Expiration 2026-12-31
Marketing Start 2025-09-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184485
Hyphenated Format 70518-4485

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
  • 100 TABLET in 1 BOTTLE, PLASTIC (70518-4485-0)
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-4485-1)
  • 30 TABLET in 1 BLISTER PACK (70518-4485-2)
source: ndc

Packages (3)

70518-4485-0 100 TABLET in 1 BOTTLE, PLASTIC (70518-4485-0) 70518-4485-1 90 TABLET in 1 BOTTLE, PLASTIC (70518-4485-1) 70518-4485-2 30 TABLET in 1 BLISTER PACK (70518-4485-2)

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": "42ed41d4-9928-5342-e063-6394a90af67e", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199247"], "spl_set_id": ["c994796e-dd3d-4f40-a8f2-d317f55e34d5"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (70518-4485-0)", "package_ndc": "70518-4485-0", "marketing_start_date": "20250928"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-4485-1)", "package_ndc": "70518-4485-1", "marketing_start_date": "20251003"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-4485-2)", "package_ndc": "70518-4485-2", "marketing_start_date": "20251105"}], "brand_name": "Glimepiride", "product_id": "70518-4485_42ed41d4-9928-5342-e063-6394a90af67e", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "70518-4485", "generic_name": "Glimepiride", "labeler_name": "REMEDYREPACK INC.", "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": "20250928", "listing_expiration_date": "20261231"}