glimepiride

Generic: glimepiride

Labeler: florida pharmaceutical products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler florida pharmaceutical products, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 4 mg/1

Manufacturer
Florida Pharmaceutical Products, LLC

Identifiers & Regulatory

Product NDC 71921-216
Product ID 71921-216_52fcdeaf-e64f-48bd-b90d-e7502b104ae1
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 71921216
Hyphenated Format 71921-216

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 ANDA202112 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (71921-216-01)
  • 500 TABLET in 1 BOTTLE (71921-216-50)
source: ndc

Packages (2)

71921-216-01 100 TABLET in 1 BOTTLE (71921-216-01) 71921-216-50 500 TABLET in 1 BOTTLE (71921-216-50)

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": "52fcdeaf-e64f-48bd-b90d-e7502b104ae1", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199245", "199246", "199247"], "spl_set_id": ["8ff0de99-272e-4e68-9caf-69f3f146ac29"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Florida Pharmaceutical Products, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (71921-216-01)", "package_ndc": "71921-216-01", "marketing_start_date": "20230731"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (71921-216-50)", "package_ndc": "71921-216-50", "marketing_start_date": "20230731"}], "brand_name": "Glimepiride", "product_id": "71921-216_52fcdeaf-e64f-48bd-b90d-e7502b104ae1", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "71921-216", "generic_name": "Glimepiride", "labeler_name": "Florida Pharmaceutical Products, LLC", "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"}