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, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 850 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8756
Product ID 68788-8756_1bb1a8f7-db48-4add-9c43-c87a272c09f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209882
Listing Expiration 2027-12-31
Marketing Start 2024-10-14

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888756
Hyphenated Format 68788-8756

Supplemental Identifiers

RxCUI
861010
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 ANDA209882 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 850 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8756-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8756-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8756-6)
  • 120 TABLET, FILM COATED in 1 BOTTLE (68788-8756-8)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8756-9)
source: ndc

Packages (5)

68788-8756-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8756-1) 68788-8756-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8756-3) 68788-8756-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8756-6) 68788-8756-8 120 TABLET, FILM COATED in 1 BOTTLE (68788-8756-8) 68788-8756-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8756-9)

Ingredients (1)

metformin hydrochloride (850 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": "1bb1a8f7-db48-4add-9c43-c87a272c09f9", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861010"], "spl_set_id": ["ca71c133-6c38-4b9e-80af-1949634157f4"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8756-1)", "package_ndc": "68788-8756-1", "marketing_start_date": "20241014"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8756-3)", "package_ndc": "68788-8756-3", "marketing_start_date": "20241014"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8756-6)", "package_ndc": "68788-8756-6", "marketing_start_date": "20241014"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (68788-8756-8)", "package_ndc": "68788-8756-8", "marketing_start_date": "20241014"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8756-9)", "package_ndc": "68788-8756-9", "marketing_start_date": "20241014"}], "brand_name": "Metformin Hydrochloride", "product_id": "68788-8756_1bb1a8f7-db48-4add-9c43-c87a272c09f9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68788-8756", "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": "850 mg/1"}], "application_number": "ANDA209882", "marketing_category": "ANDA", "marketing_start_date": "20241014", "listing_expiration_date": "20271231"}