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 2 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-630
Product ID 43063-630_47d267f8-b7ad-6cc7-e063-6294a90a1c0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078181
Listing Expiration 2027-12-31
Marketing Start 2007-08-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063630
Hyphenated Format 43063-630

Supplemental Identifiers

RxCUI
199246
UPC
0343063630303
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 ANDA078181 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-630-30)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43063-630-90)
source: ndc

Packages (2)

43063-630-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-630-30) 43063-630-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-630-90)

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": "47d267f8-b7ad-6cc7-e063-6294a90a1c0a", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0343063630303"], "unii": ["6KY687524K"], "rxcui": ["199246"], "spl_set_id": ["1b3c7d74-f80b-4fb1-8dca-66880af5d3fc"], "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 (43063-630-30)", "package_ndc": "43063-630-30", "marketing_start_date": "20151029"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-630-90)", "package_ndc": "43063-630-90", "marketing_start_date": "20151029"}], "brand_name": "Glimepiride", "product_id": "43063-630_47d267f8-b7ad-6cc7-e063-6294a90a1c0a", "dosage_form": "TABLET", "pharm_class": ["Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]"], "product_ndc": "43063-630", "generic_name": "Glimepiride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glimepiride", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "2 mg/1"}], "application_number": "ANDA078181", "marketing_category": "ANDA", "marketing_start_date": "20070823", "listing_expiration_date": "20271231"}