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
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8560
Product ID 68788-8560_a368af83-b612-4e8a-a6c3-a44fba00d85c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213320
Listing Expiration 2026-12-31
Marketing Start 2024-01-08

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888560
Hyphenated Format 68788-8560

Supplemental Identifiers

RxCUI
861004
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 ANDA213320 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8560-1)
  • 30 TABLET in 1 BOTTLE (68788-8560-3)
  • 60 TABLET in 1 BOTTLE (68788-8560-6)
  • 120 TABLET in 1 BOTTLE (68788-8560-8)
  • 90 TABLET in 1 BOTTLE (68788-8560-9)
source: ndc

Packages (5)

68788-8560-1 100 TABLET in 1 BOTTLE (68788-8560-1) 68788-8560-3 30 TABLET in 1 BOTTLE (68788-8560-3) 68788-8560-6 60 TABLET in 1 BOTTLE (68788-8560-6) 68788-8560-8 120 TABLET in 1 BOTTLE (68788-8560-8) 68788-8560-9 90 TABLET in 1 BOTTLE (68788-8560-9)

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": "a368af83-b612-4e8a-a6c3-a44fba00d85c", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004"], "spl_set_id": ["4182bcf0-1f9a-4f3a-9428-86b5d757954f"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8560-1)", "package_ndc": "68788-8560-1", "marketing_start_date": "20240108"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8560-3)", "package_ndc": "68788-8560-3", "marketing_start_date": "20240108"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8560-6)", "package_ndc": "68788-8560-6", "marketing_start_date": "20240108"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (68788-8560-8)", "package_ndc": "68788-8560-8", "marketing_start_date": "20240108"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8560-9)", "package_ndc": "68788-8560-9", "marketing_start_date": "20240108"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "68788-8560_a368af83-b612-4e8a-a6c3-a44fba00d85c", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68788-8560", "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": "1000 mg/1"}], "application_number": "ANDA213320", "marketing_category": "ANDA", "marketing_start_date": "20240108", "listing_expiration_date": "20261231"}