metformin hydrochloride

Generic: metformin hydrochloride

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler northwind health company, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 750 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-077
Product ID 51655-077_499d3590-c2be-64f0-e063-6294a90a6721
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206145
Listing Expiration 2027-12-31
Marketing Start 2022-10-05

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655077
Hyphenated Format 51655-077

Supplemental Identifiers

RxCUI
860981
UNII
786Z46389E

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 ANDA206145 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-077-26)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-077-52)
source: ndc

Packages (2)

51655-077-26 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-077-26) 51655-077-52 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-077-52)

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": "499d3590-c2be-64f0-e063-6294a90a6721", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860981"], "spl_set_id": ["f2a27d7a-ade4-421f-e053-2a95a90a01a9"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-077-26)", "package_ndc": "51655-077-26", "marketing_start_date": "20230517"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-077-52)", "package_ndc": "51655-077-52", "marketing_start_date": "20221005"}], "brand_name": "Metformin Hydrochloride", "product_id": "51655-077_499d3590-c2be-64f0-e063-6294a90a6721", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "51655-077", "generic_name": "Metformin Hydrochloride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "750 mg/1"}], "application_number": "ANDA206145", "marketing_category": "ANDA", "marketing_start_date": "20221005", "listing_expiration_date": "20271231"}