metformin hydrochloride

Generic: metformin hydrochloride

Labeler: vistapharm, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler vistapharm, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/5mL

Manufacturer
VistaPharm, LLC

Identifiers & Regulatory

Product NDC 66689-318
Product ID 66689-318_88a5077b-b1b5-47bb-ab45-32de55907ea6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212677
Listing Expiration 2026-12-31
Marketing Start 2022-12-19

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66689318
Hyphenated Format 66689-318

Supplemental Identifiers

RxCUI
861025
UNII
786Z46389E

Packaging Origin

Original Packager
true

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 ANDA212677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (66689-318-16) / 473 mL in 1 BOTTLE
source: ndc

Packages (1)

66689-318-16 1 BOTTLE in 1 CARTON (66689-318-16) / 473 mL in 1 BOTTLE

Ingredients (1)

metformin hydrochloride (500 mg/5mL)

Linked Drug Pages (1)

Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "88a5077b-b1b5-47bb-ab45-32de55907ea6", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861025"], "spl_set_id": ["e087ce3b-8d7f-43a3-8d20-54513da7617d"], "manufacturer_name": ["VistaPharm, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (66689-318-16)  / 473 mL in 1 BOTTLE", "package_ndc": "66689-318-16", "marketing_start_date": "20221219"}], "brand_name": "Metformin Hydrochloride", "product_id": "66689-318_88a5077b-b1b5-47bb-ab45-32de55907ea6", "dosage_form": "SOLUTION", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "66689-318", "generic_name": "Metformin Hydrochloride", "labeler_name": "VistaPharm, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/5mL"}], "application_number": "ANDA212677", "marketing_category": "ANDA", "marketing_start_date": "20221219", "listing_expiration_date": "20261231"}