metformin hcl

Generic: metformin hcl

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hcl
Generic Name metformin hcl
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-561
Product ID 67877-561_2d98aea3-35ba-447a-b88f-a5a20b612b2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2017-02-06

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877561
Hyphenated Format 67877-561

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0367877561011 0367877563015
UNII
786Z46389E

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 metformin hcl (source: ndc)
Generic Name metformin hcl (source: ndc)
Application Number ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (67877-561-01)
  • 500 TABLET in 1 BOTTLE (67877-561-05)
  • 1000 TABLET in 1 BOTTLE (67877-561-10)
source: ndc

Packages (3)

67877-561-01 100 TABLET in 1 BOTTLE (67877-561-01) 67877-561-05 500 TABLET in 1 BOTTLE (67877-561-05) 67877-561-10 1000 TABLET in 1 BOTTLE (67877-561-10)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Metformin HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d98aea3-35ba-447a-b88f-a5a20b612b2f", "openfda": {"upc": ["0367877561011", "0367877563015"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["2d98aea3-35ba-447a-b88f-a5a20b612b2f"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (67877-561-01)", "package_ndc": "67877-561-01", "marketing_start_date": "20170206"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (67877-561-05)", "package_ndc": "67877-561-05", "marketing_start_date": "20170206"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (67877-561-10)", "package_ndc": "67877-561-10", "marketing_start_date": "20170206"}], "brand_name": "Metformin HCl", "product_id": "67877-561_2d98aea3-35ba-447a-b88f-a5a20b612b2f", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "67877-561", "generic_name": "Metformin HCl", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin HCl", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20170206", "listing_expiration_date": "20261231"}