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 850 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8528
Product ID 68788-8528_451d8f5f-5f21-4f87-8f1b-4c4159055ccf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2023-10-06

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888528
Hyphenated Format 68788-8528

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 ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 850 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8528-1)
  • 30 TABLET in 1 BOTTLE (68788-8528-3)
  • 60 TABLET in 1 BOTTLE (68788-8528-6)
  • 120 TABLET in 1 BOTTLE (68788-8528-8)
  • 90 TABLET in 1 BOTTLE (68788-8528-9)
source: ndc

Packages (5)

68788-8528-1 100 TABLET in 1 BOTTLE (68788-8528-1) 68788-8528-3 30 TABLET in 1 BOTTLE (68788-8528-3) 68788-8528-6 60 TABLET in 1 BOTTLE (68788-8528-6) 68788-8528-8 120 TABLET in 1 BOTTLE (68788-8528-8) 68788-8528-9 90 TABLET in 1 BOTTLE (68788-8528-9)

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": "451d8f5f-5f21-4f87-8f1b-4c4159055ccf", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861010"], "spl_set_id": ["902d1bc4-3f1f-4a1a-86d7-cf98c56a3684"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8528-1)", "package_ndc": "68788-8528-1", "marketing_start_date": "20231006"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8528-3)", "package_ndc": "68788-8528-3", "marketing_start_date": "20231006"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8528-6)", "package_ndc": "68788-8528-6", "marketing_start_date": "20231006"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (68788-8528-8)", "package_ndc": "68788-8528-8", "marketing_start_date": "20231006"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8528-9)", "package_ndc": "68788-8528-9", "marketing_start_date": "20231006"}], "brand_name": "Metformin Hydrochloride", "product_id": "68788-8528_451d8f5f-5f21-4f87-8f1b-4c4159055ccf", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68788-8528", "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": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20231006", "listing_expiration_date": "20261231"}