metformin hydrochloride

Generic: metformin hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2568
Product ID 71335-2568_b59e65e1-5676-4535-920b-88b8becefc10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217631
Listing Expiration 2026-12-31
Marketing Start 2023-10-06

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713352568
Hyphenated Format 71335-2568

Supplemental Identifiers

RxCUI
860975
UNII
786Z46389E

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 ANDA217631 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-1)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-2)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-3)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-4)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-5)
  • 15 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-6)
  • 45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-7)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-8)
  • 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-9)
source: ndc

Packages (9)

71335-2568-1 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-1) 71335-2568-2 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-2) 71335-2568-3 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-3) 71335-2568-4 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-4) 71335-2568-5 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-5) 71335-2568-6 15 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-6) 71335-2568-7 45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-7) 71335-2568-8 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-8) 71335-2568-9 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-9)

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": "b59e65e1-5676-4535-920b-88b8becefc10", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["4db5551b-04f6-4921-9dee-68acb41f7f71"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-1)", "package_ndc": "71335-2568-1", "marketing_start_date": "20250205"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-2)", "package_ndc": "71335-2568-2", "marketing_start_date": "20250205"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-3)", "package_ndc": "71335-2568-3", "marketing_start_date": "20250205"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-4)", "package_ndc": "71335-2568-4", "marketing_start_date": "20250205"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-5)", "package_ndc": "71335-2568-5", "marketing_start_date": "20250205"}, {"sample": false, "description": "15 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-6)", "package_ndc": "71335-2568-6", "marketing_start_date": "20250205"}, {"sample": false, "description": "45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-7)", "package_ndc": "71335-2568-7", "marketing_start_date": "20250205"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-8)", "package_ndc": "71335-2568-8", "marketing_start_date": "20250205"}, {"sample": false, "description": "20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-9)", "package_ndc": "71335-2568-9", "marketing_start_date": "20250205"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "71335-2568_b59e65e1-5676-4535-920b-88b8becefc10", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71335-2568", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA217631", "marketing_category": "ANDA", "marketing_start_date": "20231006", "listing_expiration_date": "20261231"}