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 500 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8903
Product ID 68788-8903_e55ee270-5eb9-4848-8529-9af2a79669c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078321
Listing Expiration 2026-12-31
Marketing Start 2025-07-31

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888903
Hyphenated Format 68788-8903

Supplemental Identifiers

RxCUI
860975
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 ANDA078321 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-1)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-3)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-6)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-8)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-9)
source: ndc

Packages (5)

68788-8903-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-1) 68788-8903-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-3) 68788-8903-6 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-6) 68788-8903-8 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-8) 68788-8903-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-9)

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": "e55ee270-5eb9-4848-8529-9af2a79669c0", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["e55ee270-5eb9-4848-8529-9af2a79669c0"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-1)", "package_ndc": "68788-8903-1", "marketing_start_date": "20250731"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-3)", "package_ndc": "68788-8903-3", "marketing_start_date": "20250731"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-6)", "package_ndc": "68788-8903-6", "marketing_start_date": "20250731"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-8)", "package_ndc": "68788-8903-8", "marketing_start_date": "20250731"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-9)", "package_ndc": "68788-8903-9", "marketing_start_date": "20250731"}], "brand_name": "Metformin Hydrochloride", "product_id": "68788-8903_e55ee270-5eb9-4848-8529-9af2a79669c0", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68788-8903", "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": "500 mg/1"}], "application_number": "ANDA078321", "marketing_category": "ANDA", "marketing_start_date": "20250731", "listing_expiration_date": "20261231"}