glimepiride

Generic: glimepiride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glimepiride
Generic Name glimepiride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 4 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-122
Product ID 43063-122_41372f7a-4296-6e3d-e063-6394a90af659
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077091
Listing Expiration 2026-12-31
Marketing Start 2005-10-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063122
Hyphenated Format 43063-122

Supplemental Identifiers

RxCUI
199247
UPC
0343063122907
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
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-122-30)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43063-122-90)
source: ndc

Packages (2)

43063-122-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-122-30) 43063-122-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-122-90)

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": "41372f7a-4296-6e3d-e063-6394a90af659", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0343063122907"], "unii": ["6KY687524K"], "rxcui": ["199247"], "spl_set_id": ["101cdc41-2131-4425-b550-6a0a60b5f4a4"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-122-30)", "package_ndc": "43063-122-30", "marketing_start_date": "20241219"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-122-90)", "package_ndc": "43063-122-90", "marketing_start_date": "20091223"}], "brand_name": "Glimepiride", "product_id": "43063-122_41372f7a-4296-6e3d-e063-6394a90af659", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "43063-122", "generic_name": "Glimepiride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20051006", "listing_expiration_date": "20261231"}