metformin hydrochloride oral solution (52817-821)

Drug Facts

Product Profile

Brand Name metformin hydrochloride oral solution

Generic Name metformin hydrochloride

Labeler trupharma, llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

metformin hydrochloride 500 mg/5mL

Manufacturer

TRUPHARMA, LLC

Identifiers & Regulatory

Product NDC 52817-821

Product ID 52817-821_2a4320c6-8080-9ddc-e063-6294a90aa921

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211309

Listing Expiration 2026-12-31

Marketing Start 2022-01-25

Pharmacologic Class

Classes

biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52817821

Hyphenated Format 52817-821

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 oral solution (source: ndc)

Generic Name metformin hydrochloride (source: ndc)

Application Number ANDA211309 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

500 mg/5mL

source: ndc

Packaging

5 TRAY in 1 CASE (52817-821-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 8.5 mL in 1 CUP, UNIT-DOSE

source: ndc

Packages (1)

52817-821-50 5 TRAY in 1 CASE (52817-821-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 8.5 mL in 1 CUP, UNIT-DOSE

Ingredients (1)

metformin hydrochloride (500 mg/5mL)

Linked Drug Pages (1)

Metformin Hydrochloride Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2a4320c6-8080-9ddc-e063-6294a90aa921", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861025"], "spl_set_id": ["73691c6c-8841-4c5d-b4a5-c3ed3b5effa1"], "manufacturer_name": ["TRUPHARMA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 TRAY in 1 CASE (52817-821-50)  / 10 CUP, UNIT-DOSE in 1 TRAY / 8.5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "52817-821-50", "marketing_start_date": "20220125"}], "brand_name": "Metformin Hydrochloride Oral Solution", "product_id": "52817-821_2a4320c6-8080-9ddc-e063-6294a90aa921", "dosage_form": "SOLUTION", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "52817-821", "generic_name": "Metformin Hydrochloride", "labeler_name": "TRUPHARMA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride Oral Solution", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/5mL"}], "application_number": "ANDA211309", "marketing_category": "ANDA", "marketing_start_date": "20220125", "listing_expiration_date": "20261231"}