metformin hydrochloride

Generic: metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-823
Product ID 10135-823_3e9d939c-6815-c5db-e063-6394a90ac9c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202306
Listing Expiration 2026-12-31
Marketing Start 2025-08-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135823
Hyphenated Format 10135-823

Supplemental Identifiers

RxCUI
860975 860981
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 ANDA202306 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-05)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-10)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-30)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-32)
  • 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-33)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-60)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-62)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-90)
source: ndc

Packages (8)

10135-823-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-05) 10135-823-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-10) 10135-823-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-30) 10135-823-32 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-32) 10135-823-33 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-33) 10135-823-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-60) 10135-823-62 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-62) 10135-823-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-90)

Ingredients (1)

metformin hydrochloride (500 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": "3e9d939c-6815-c5db-e063-6394a90ac9c2", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["3d6f397b-e909-bee9-e063-6294a90aba17"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-05)", "package_ndc": "10135-823-05", "marketing_start_date": "20250801"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-10)", "package_ndc": "10135-823-10", "marketing_start_date": "20250801"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-30)", "package_ndc": "10135-823-30", "marketing_start_date": "20250801"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-32)", "package_ndc": "10135-823-32", "marketing_start_date": "20250801"}, {"sample": false, "description": "360 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-33)", "package_ndc": "10135-823-33", "marketing_start_date": "20250801"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-60)", "package_ndc": "10135-823-60", "marketing_start_date": "20250801"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-62)", "package_ndc": "10135-823-62", "marketing_start_date": "20250801"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-90)", "package_ndc": "10135-823-90", "marketing_start_date": "20250801"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "10135-823_3e9d939c-6815-c5db-e063-6394a90ac9c2", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "10135-823", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA202306", "marketing_category": "ANDA", "marketing_start_date": "20250801", "listing_expiration_date": "20261231"}