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 1000 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8520
Product ID 68788-8520_31db7f39-af80-4131-9ef5-96fb74fdd623
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090692
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888520
Hyphenated Format 68788-8520

Supplemental Identifiers

RxCUI
1807894
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 ANDA090692 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8520-6)
source: ndc

Packages (1)

68788-8520-6 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8520-6)

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": "31db7f39-af80-4131-9ef5-96fb74fdd623", "openfda": {"unii": ["786Z46389E"], "rxcui": ["1807894"], "spl_set_id": ["14238afd-200d-4a05-b731-647c43cecbc3"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8520-6)", "package_ndc": "68788-8520-6", "marketing_start_date": "20230901"}], "brand_name": "Metformin Hydrochloride", "product_id": "68788-8520_31db7f39-af80-4131-9ef5-96fb74fdd623", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68788-8520", "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": "ANDA090692", "marketing_category": "ANDA", "marketing_start_date": "20230901", "listing_expiration_date": "20261231"}