metformin

Generic: metformin er 500 mg

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

Drug Facts

Product Profile

Brand Name metformin
Generic Name metformin er 500 mg
Labeler remedyrepack inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4370
Product ID 70518-4370_3cf39c3e-e7c6-c6d6-e063-6294a90aede4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209313
Listing Expiration 2026-12-31
Marketing Start 2025-06-24

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184370
Hyphenated Format 70518-4370

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 (source: ndc)
Generic Name metformin er 500 mg (source: ndc)
Application Number ANDA209313 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4370-0)
  • 100 POUCH in 1 BOX (70518-4370-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4370-2)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4370-3)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4370-4)
source: ndc

Packages (4)

70518-4370-0 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4370-0) 70518-4370-1 100 POUCH in 1 BOX (70518-4370-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4370-2) 70518-4370-3 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4370-3) 70518-4370-4 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4370-4)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Metformin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3cf39c3e-e7c6-c6d6-e063-6294a90aede4", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["05999192-ebc6-4198-bd1e-f46abbfb4f8a"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4370-0)", "package_ndc": "70518-4370-0", "marketing_start_date": "20250624"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-4370-1)  / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4370-2)", "package_ndc": "70518-4370-1", "marketing_start_date": "20250624"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4370-3)", "package_ndc": "70518-4370-3", "marketing_start_date": "20250721"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4370-4)", "package_ndc": "70518-4370-4", "marketing_start_date": "20250822"}], "brand_name": "Metformin", "product_id": "70518-4370_3cf39c3e-e7c6-c6d6-e063-6294a90aede4", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "70518-4370", "generic_name": "Metformin ER 500 mg", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA209313", "marketing_category": "ANDA", "marketing_start_date": "20250624", "listing_expiration_date": "20261231"}