glimepiride

Generic: glimepiride

Labeler: carlsbad technology, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler carlsbad technology, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 2 mg/1

Manufacturer
Carlsbad Technology, Inc.

Identifiers & Regulatory

Product NDC 61442-116
Product ID 61442-116_2386d706-9dab-4ae0-e063-6394a90a8a06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077911
Listing Expiration 2026-12-31
Marketing Start 2012-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61442116
Hyphenated Format 61442-116

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 ANDA077911 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (61442-116-01)
  • 500 TABLET in 1 BOTTLE (61442-116-05)
  • 1000 TABLET in 1 BOTTLE (61442-116-10)
source: ndc

Packages (3)

61442-116-01 100 TABLET in 1 BOTTLE (61442-116-01) 61442-116-05 500 TABLET in 1 BOTTLE (61442-116-05) 61442-116-10 1000 TABLET in 1 BOTTLE (61442-116-10)

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": "2386d706-9dab-4ae0-e063-6394a90a8a06", "openfda": {"nui": ["N0000175608", "M0020795"], "unii": ["6KY687524K"], "rxcui": ["199245", "199246", "199247"], "spl_set_id": ["72d88c6d-2f0a-4bf8-aa7f-1e1811794187"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Carlsbad Technology, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (61442-116-01)", "package_ndc": "61442-116-01", "marketing_start_date": "20120101"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (61442-116-05)", "package_ndc": "61442-116-05", "marketing_start_date": "20120101"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (61442-116-10)", "package_ndc": "61442-116-10", "marketing_start_date": "20120101"}], "brand_name": "Glimepiride", "product_id": "61442-116_2386d706-9dab-4ae0-e063-6394a90a8a06", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "61442-116", "generic_name": "Glimepiride", "labeler_name": "Carlsbad Technology, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "2 mg/1"}], "application_number": "ANDA077911", "marketing_category": "ANDA", "marketing_start_date": "20120101", "listing_expiration_date": "20261231"}