metformin hydrochloride (68788-8498)

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 500 mg/1

Manufacturer

Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8498

Product ID 68788-8498_bc2f564b-191f-4096-8513-40e22986899d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209882

Listing Expiration 2026-12-31

Marketing Start 2023-08-01

Pharmacologic Class

Classes

biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888498

Hyphenated Format 68788-8498

Supplemental Identifiers

RxCUI

861007

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

500 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (68788-8498-1)
30 TABLET, FILM COATED in 1 BOTTLE (68788-8498-3)
60 TABLET, FILM COATED in 1 BOTTLE (68788-8498-6)
180 TABLET, FILM COATED in 1 BOTTLE (68788-8498-7)
120 TABLET, FILM COATED in 1 BOTTLE (68788-8498-8)
90 TABLET, FILM COATED in 1 BOTTLE (68788-8498-9)

source: ndc

Packages (6)

68788-8498-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8498-1) 68788-8498-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8498-3) 68788-8498-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8498-6) 68788-8498-7 180 TABLET, FILM COATED in 1 BOTTLE (68788-8498-7) 68788-8498-8 120 TABLET, FILM COATED in 1 BOTTLE (68788-8498-8) 68788-8498-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8498-9)

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": "bc2f564b-191f-4096-8513-40e22986899d", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861007"], "spl_set_id": ["0f251f2c-97f3-4048-84f2-81fea03685aa"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8498-1)", "package_ndc": "68788-8498-1", "marketing_start_date": "20230801"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8498-3)", "package_ndc": "68788-8498-3", "marketing_start_date": "20230801"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8498-6)", "package_ndc": "68788-8498-6", "marketing_start_date": "20230801"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (68788-8498-7)", "package_ndc": "68788-8498-7", "marketing_start_date": "20230801"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (68788-8498-8)", "package_ndc": "68788-8498-8", "marketing_start_date": "20230801"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8498-9)", "package_ndc": "68788-8498-9", "marketing_start_date": "20230801"}], "brand_name": "Metformin Hydrochloride", "product_id": "68788-8498_bc2f564b-191f-4096-8513-40e22986899d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68788-8498", "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": "ANDA209882", "marketing_category": "ANDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}