metformin hydrochloride

Generic: metformin hydrochloride

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

Drug Facts

Product Profile

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

metformin hydrochloride 1000 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4369
Product ID 70518-4369_3852dad0-7b83-5c22-e063-6294a90aa2aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090692
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 705184369
Hyphenated Format 70518-4369

Supplemental Identifiers

RxCUI
1807894
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 ANDA090692 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX (70518-4369-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4369-1)
source: ndc

Packages (1)

70518-4369-0 30 POUCH in 1 BOX (70518-4369-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4369-1)

Ingredients (1)

metformin hydrochloride (1000 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": "3852dad0-7b83-5c22-e063-6294a90aa2aa", "openfda": {"unii": ["786Z46389E"], "rxcui": ["1807894"], "spl_set_id": ["d5228e81-9c86-4781-b984-20feaa2ae779"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 BOX (70518-4369-0)  / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4369-1)", "package_ndc": "70518-4369-0", "marketing_start_date": "20250624"}], "brand_name": "Metformin Hydrochloride", "product_id": "70518-4369_3852dad0-7b83-5c22-e063-6294a90aa2aa", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "70518-4369", "generic_name": "Metformin Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA090692", "marketing_category": "ANDA", "marketing_start_date": "20250624", "listing_expiration_date": "20261231"}