glimepiride

Generic: glimepiride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 2 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3639
Product ID 68071-3639_1c336dcb-ba7c-a01b-e063-6294a90a4845
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 680713639
Hyphenated Format 68071-3639

Supplemental Identifiers

RxCUI
199246
UPC
0368071363982
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
  • 2 mg/1
source: ndc
Packaging
  • 180 TABLET in 1 BOTTLE (68071-3639-8)
source: ndc

Packages (1)

68071-3639-8 180 TABLET in 1 BOTTLE (68071-3639-8)

Ingredients (1)

glimepiride (2 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": "1c336dcb-ba7c-a01b-e063-6294a90a4845", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0368071363982"], "unii": ["6KY687524K"], "rxcui": ["199246"], "spl_set_id": ["1c335fc7-24d0-5526-e063-6394a90a488e"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET in 1 BOTTLE (68071-3639-8)", "package_ndc": "68071-3639-8", "marketing_start_date": "20240701"}], "brand_name": "Glimepiride", "product_id": "68071-3639_1c336dcb-ba7c-a01b-e063-6294a90a4845", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "68071-3639", "generic_name": "Glimepiride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "2 mg/1"}], "application_number": "ANDA202112", "marketing_category": "ANDA", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}