glimepiride

Generic: glimepiride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 2 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-774
Product ID 16571-774_f06a97e3-4349-4df3-87de-4479c1ed69bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202759
Listing Expiration 2027-12-31
Marketing Start 2012-06-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571774
Hyphenated Format 16571-774

Supplemental Identifiers

RxCUI
199245 199246 199247
UPC
0316571774012 0316571773015 0316571775019
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 ANDA202759 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16571-774-01)
  • 500 TABLET in 1 BOTTLE (16571-774-50)
source: ndc

Packages (2)

16571-774-01 100 TABLET in 1 BOTTLE (16571-774-01) 16571-774-50 500 TABLET in 1 BOTTLE (16571-774-50)

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": "f06a97e3-4349-4df3-87de-4479c1ed69bc", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0316571774012", "0316571773015", "0316571775019"], "unii": ["6KY687524K"], "rxcui": ["199245", "199246", "199247"], "spl_set_id": ["48ada723-8144-497d-afd6-a8c52a1dd3ff"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16571-774-01)", "package_ndc": "16571-774-01", "marketing_start_date": "20120629"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16571-774-50)", "package_ndc": "16571-774-50", "marketing_start_date": "20120629"}], "brand_name": "Glimepiride", "product_id": "16571-774_f06a97e3-4349-4df3-87de-4479c1ed69bc", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "16571-774", "generic_name": "Glimepiride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "2 mg/1"}], "application_number": "ANDA202759", "marketing_category": "ANDA", "marketing_start_date": "20120629", "listing_expiration_date": "20271231"}