metformin hydrochloride

Generic: metformin hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 750 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-240
Product ID 33342-240_3ce6010c-10dd-4e6f-9517-d71c0489a7c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206955
Listing Expiration 2026-12-31
Marketing Start 2016-12-08

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342240
Hyphenated Format 33342-240

Supplemental Identifiers

RxCUI
860975 860981 861004 861007 861010
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 ANDA206955 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-240-11)
source: ndc

Packages (1)

33342-240-11 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-240-11)

Ingredients (1)

metformin hydrochloride (750 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": "3ce6010c-10dd-4e6f-9517-d71c0489a7c5", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975", "860981", "861004", "861007", "861010"], "spl_set_id": ["623b3bc6-1b07-4a04-bc7a-7fc695adf063"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-240-11)", "package_ndc": "33342-240-11", "marketing_start_date": "20161208"}], "brand_name": "Metformin hydrochloride", "product_id": "33342-240_3ce6010c-10dd-4e6f-9517-d71c0489a7c5", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "33342-240", "generic_name": "Metformin hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "750 mg/1"}], "application_number": "ANDA206955", "marketing_category": "ANDA", "marketing_start_date": "20161208", "listing_expiration_date": "20261231"}