metformin hydrochloride

Generic: metformin hydrochloride

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2125
Product ID 69238-2125_7e91bdf3-12b0-4816-b607-6c42b9d99df7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078596
Listing Expiration 2027-12-31
Marketing Start 2009-12-02

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692382125
Hyphenated Format 69238-2125

Supplemental Identifiers

RxCUI
860975 860981
UPC
0369238212617 0369238212518
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 ANDA078596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-1)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-3)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-5)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-7)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-9)
source: ndc

Packages (5)

69238-2125-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-1) 69238-2125-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-3) 69238-2125-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-5) 69238-2125-7 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-7) 69238-2125-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-9)

Ingredients (1)

metformin hydrochloride (500 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": "7e91bdf3-12b0-4816-b607-6c42b9d99df7", "openfda": {"upc": ["0369238212617", "0369238212518"], "unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["dc65065b-cba0-46d7-8fb5-3368f3210b4d"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-1)", "package_ndc": "69238-2125-1", "marketing_start_date": "20091202"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-3)", "package_ndc": "69238-2125-3", "marketing_start_date": "20091202"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-5)", "package_ndc": "69238-2125-5", "marketing_start_date": "20091202"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-7)", "package_ndc": "69238-2125-7", "marketing_start_date": "20091202"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-9)", "package_ndc": "69238-2125-9", "marketing_start_date": "20091202"}], "brand_name": "Metformin Hydrochloride", "product_id": "69238-2125_7e91bdf3-12b0-4816-b607-6c42b9d99df7", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "69238-2125", "generic_name": "Metformin Hydrochloride", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA078596", "marketing_category": "ANDA", "marketing_start_date": "20091202", "listing_expiration_date": "20271231"}