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 1000 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-378
Product ID 33342-378_2737f784-07ad-4e5a-862f-beaea31d005e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211163
Listing Expiration 2026-12-31
Marketing Start 2024-03-13

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342378
Hyphenated Format 33342-378

Supplemental Identifiers

RxCUI
1807888
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 ANDA211163 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-378-10)
source: ndc

Packages (1)

33342-378-10 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-378-10)

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": "2737f784-07ad-4e5a-862f-beaea31d005e", "openfda": {"unii": ["786Z46389E"], "rxcui": ["1807888"], "spl_set_id": ["2737f784-07ad-4e5a-862f-beaea31d005e"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-378-10)", "package_ndc": "33342-378-10", "marketing_start_date": "20240313"}], "brand_name": "Metformin Hydrochloride", "product_id": "33342-378_2737f784-07ad-4e5a-862f-beaea31d005e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "33342-378", "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": "1000 mg/1"}], "application_number": "ANDA211163", "marketing_category": "ANDA", "marketing_start_date": "20240313", "listing_expiration_date": "20261231"}