glimepiride

Generic: glimepiride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 4 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-360
Product ID 50268-360_4860dfbf-405a-6b0f-e063-6394a90af79c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077091
Listing Expiration 2027-12-31
Marketing Start 2019-10-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268360
Hyphenated Format 50268-360

Supplemental Identifiers

RxCUI
199245 199246 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 ANDA077091 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-360-15) / 1 TABLET in 1 BLISTER PACK (50268-360-11)
source: ndc

Packages (1)

50268-360-15 50 BLISTER PACK in 1 BOX (50268-360-15) / 1 TABLET in 1 BLISTER PACK (50268-360-11)

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": "4860dfbf-405a-6b0f-e063-6394a90af79c", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199245", "199246", "199247"], "spl_set_id": ["93f1e064-fcbd-e8fd-e053-2995a90a5dbb"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-360-15)  / 1 TABLET in 1 BLISTER PACK (50268-360-11)", "package_ndc": "50268-360-15", "marketing_start_date": "20191002"}], "brand_name": "Glimepiride", "product_id": "50268-360_4860dfbf-405a-6b0f-e063-6394a90af79c", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "50268-360", "generic_name": "Glimepiride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "4 mg/1"}], "application_number": "ANDA077091", "marketing_category": "ANDA", "marketing_start_date": "20191002", "listing_expiration_date": "20271231"}