metformin hydrochloride

Generic: metformin hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 750 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8532
Product ID 68788-8532_c7571e06-7334-4c30-be0e-35a624f183bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077336
Listing Expiration 2026-12-31
Marketing Start 2023-10-03

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888532
Hyphenated Format 68788-8532

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 ANDA077336 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8532-1)
source: ndc

Packages (1)

Ingredients (1)

metformin hydrochloride (750 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "c7571e06-7334-4c30-be0e-35a624f183bb", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860981"], "spl_set_id": ["676b38b2-17dc-45ab-a7ac-dc2f6258ac46"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8532-1)", "package_ndc": "68788-8532-1", "marketing_start_date": "20231003"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "68788-8532_c7571e06-7334-4c30-be0e-35a624f183bb", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68788-8532", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "750 mg/1"}], "application_number": "ANDA077336", "marketing_category": "ANDA", "marketing_start_date": "20231003", "listing_expiration_date": "20261231"}