metformin hydrochloride oral solution

Generic: metformin hydrochloride

Labeler: bionpharma inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride oral solution
Generic Name metformin hydrochloride
Labeler bionpharma inc.,
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/5mL

Manufacturer
Bionpharma Inc.,

Identifiers & Regulatory

Product NDC 69452-380
Product ID 69452-380_4ba93003-acad-5cab-e063-6394a90afa98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219151
Listing Expiration 2027-12-31
Marketing Start 2025-07-28

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452380
Hyphenated Format 69452-380

Supplemental Identifiers

RxCUI
861025
UPC
0369452380888
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 ANDA219151 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (69452-380-55)
  • 473 mL in 1 BOTTLE (69452-380-88)
source: ndc

Packages (2)

69452-380-55 118 mL in 1 BOTTLE (69452-380-55) 69452-380-88 473 mL in 1 BOTTLE (69452-380-88)

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": "4ba93003-acad-5cab-e063-6394a90afa98", "openfda": {"upc": ["0369452380888"], "unii": ["786Z46389E"], "rxcui": ["861025"], "spl_set_id": ["3ab005d4-bc99-4fdb-e063-6394a90a5124"], "manufacturer_name": ["Bionpharma Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (69452-380-55)", "package_ndc": "69452-380-55", "marketing_start_date": "20260226"}, {"sample": false, "description": "473 mL in 1 BOTTLE (69452-380-88)", "package_ndc": "69452-380-88", "marketing_start_date": "20250728"}], "brand_name": "Metformin Hydrochloride Oral Solution", "product_id": "69452-380_4ba93003-acad-5cab-e063-6394a90afa98", "dosage_form": "SOLUTION", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "69452-380", "generic_name": "Metformin Hydrochloride", "labeler_name": "Bionpharma Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride Oral Solution", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/5mL"}], "application_number": "ANDA219151", "marketing_category": "ANDA", "marketing_start_date": "20250728", "listing_expiration_date": "20271231"}