glimepiride

Generic: glimepiride

Labeler: solco healthcare u.s., llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler solco healthcare u.s., llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 1 mg/1

Manufacturer
Solco Healthcare U.S., LLC

Identifiers & Regulatory

Product NDC 43547-394
Product ID 43547-394_95a5568d-751c-4497-b70c-5cc358bbb2af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077370
Listing Expiration 2026-12-31
Marketing Start 2017-01-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547394
Hyphenated Format 43547-394

Supplemental Identifiers

RxCUI
199245 199246 199247
UNII
6KY687524K
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 glimepiride (source: ndc)
Generic Name glimepiride (source: ndc)
Application Number ANDA077370 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (43547-394-10)
  • 500 TABLET in 1 BOTTLE, PLASTIC (43547-394-50)
source: ndc

Packages (2)

43547-394-10 100 TABLET in 1 BOTTLE, PLASTIC (43547-394-10) 43547-394-50 500 TABLET in 1 BOTTLE, PLASTIC (43547-394-50)

Ingredients (1)

glimepiride (1 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": "95a5568d-751c-4497-b70c-5cc358bbb2af", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199245", "199246", "199247"], "spl_set_id": ["86acdd9e-8637-43e4-8bf7-b3a123b871b8"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Solco Healthcare U.S., LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (43547-394-10)", "package_ndc": "43547-394-10", "marketing_start_date": "20170130"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (43547-394-50)", "package_ndc": "43547-394-50", "marketing_start_date": "20170130"}], "brand_name": "Glimepiride", "product_id": "43547-394_95a5568d-751c-4497-b70c-5cc358bbb2af", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "43547-394", "generic_name": "glimepiride", "labeler_name": "Solco Healthcare U.S., LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "1 mg/1"}], "application_number": "ANDA077370", "marketing_category": "ANDA", "marketing_start_date": "20170130", "listing_expiration_date": "20261231"}