metformin hydrochloride er

Generic: metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name metformin hydrochloride er
Generic Name metformin hydrochloride
Labeler leading pharma, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-410
Product ID 69315-410_3383dbe6-8796-a02d-e063-6294a90a4a5c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201991
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315410
Hyphenated Format 69315-410

Supplemental Identifiers

RxCUI
860975
UPC
0369315410011
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 er (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA201991 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-05)
source: ndc

Packages (2)

69315-410-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-01) 69315-410-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-05)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

METFORMIN HYDROCHLORIDE ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3383dbe6-8796-a02d-e063-6294a90a4a5c", "openfda": {"upc": ["0369315410011"], "unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["3dca884d-ec44-496f-9eeb-31fd8fa3f574"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-01)", "package_ndc": "69315-410-01", "marketing_start_date": "20250501"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-05)", "package_ndc": "69315-410-05", "marketing_start_date": "20250501"}], "brand_name": "METFORMIN HYDROCHLORIDE ER", "product_id": "69315-410_3383dbe6-8796-a02d-e063-6294a90a4a5c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "69315-410", "generic_name": "metformin hydrochloride", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "brand_name_suffix": "ER", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA201991", "marketing_category": "ANDA", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}