metformin hydrochloride

Generic: metformin hydrochloride

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

Drug Facts

Product Profile

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

metformin hydrochloride 1000 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-221
Product ID 67877-221_4fa6bd66-7f2c-4b63-9809-be460cbc2527
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091184
Listing Expiration 2026-12-31
Marketing Start 2011-01-31

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877221
Hyphenated Format 67877-221

Supplemental Identifiers

RxCUI
860975 860981 861004 861007 861010
UPC
0367877221014 0367877218014 0367877414904 0367877413907
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 hydrochloride (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA091184 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (67877-221-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (67877-221-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (67877-221-10)
  • 10 BLISTER PACK in 1 CARTON (67877-221-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-221-33)
source: ndc

Packages (4)

67877-221-01 100 TABLET, FILM COATED in 1 BOTTLE (67877-221-01) 67877-221-05 500 TABLET, FILM COATED in 1 BOTTLE (67877-221-05) 67877-221-10 1000 TABLET, FILM COATED in 1 BOTTLE (67877-221-10) 67877-221-38 10 BLISTER PACK in 1 CARTON (67877-221-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-221-33)

Ingredients (1)

metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4fa6bd66-7f2c-4b63-9809-be460cbc2527", "openfda": {"upc": ["0367877221014", "0367877218014", "0367877414904", "0367877413907"], "unii": ["786Z46389E"], "rxcui": ["860975", "860981", "861004", "861007", "861010"], "spl_set_id": ["0ff1ba75-3c86-4baf-a6b1-1bb883839866"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (67877-221-01)", "package_ndc": "67877-221-01", "marketing_start_date": "20110131"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (67877-221-05)", "package_ndc": "67877-221-05", "marketing_start_date": "20110131"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (67877-221-10)", "package_ndc": "67877-221-10", "marketing_start_date": "20110131"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-221-38)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-221-33)", "package_ndc": "67877-221-38", "marketing_start_date": "20110131"}], "brand_name": "Metformin Hydrochloride", "product_id": "67877-221_4fa6bd66-7f2c-4b63-9809-be460cbc2527", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "67877-221", "generic_name": "Metformin Hydrochloride", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA091184", "marketing_category": "ANDA", "marketing_start_date": "20110131", "listing_expiration_date": "20261231"}