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
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3101
Product ID 70518-3101_3a0fd265-1fab-88eb-e063-6294a90a2ae7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2021-05-24

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183101
Hyphenated Format 70518-3101

Supplemental Identifiers

RxCUI
861004
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 ANDA090564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-3101-0)
  • 180 TABLET in 1 BOTTLE, PLASTIC (70518-3101-1)
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-3101-2)
  • 30 TABLET in 1 BLISTER PACK (70518-3101-4)
  • 60 TABLET in 1 BOTTLE, PLASTIC (70518-3101-5)
  • 100 TABLET in 1 BOTTLE, PLASTIC (70518-3101-6)
source: ndc

Packages (6)

70518-3101-0 30 TABLET in 1 BLISTER PACK (70518-3101-0) 70518-3101-1 180 TABLET in 1 BOTTLE, PLASTIC (70518-3101-1) 70518-3101-2 90 TABLET in 1 BOTTLE, PLASTIC (70518-3101-2) 70518-3101-4 30 TABLET in 1 BLISTER PACK (70518-3101-4) 70518-3101-5 60 TABLET in 1 BOTTLE, PLASTIC (70518-3101-5) 70518-3101-6 100 TABLET in 1 BOTTLE, PLASTIC (70518-3101-6)

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": "3a0fd265-1fab-88eb-e063-6294a90a2ae7", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004"], "spl_set_id": ["59a4ccda-5487-4ac4-9373-0c0fc8b7c88b"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3101-0)", "package_ndc": "70518-3101-0", "marketing_start_date": "20210524"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (70518-3101-1)", "package_ndc": "70518-3101-1", "marketing_start_date": "20220726"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-3101-2)", "package_ndc": "70518-3101-2", "marketing_start_date": "20220729"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3101-4)", "package_ndc": "70518-3101-4", "marketing_start_date": "20240320"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (70518-3101-5)", "package_ndc": "70518-3101-5", "marketing_start_date": "20241209"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (70518-3101-6)", "package_ndc": "70518-3101-6", "marketing_start_date": "20250319"}], "brand_name": "Metformin Hydrochloride", "product_id": "70518-3101_3a0fd265-1fab-88eb-e063-6294a90a2ae7", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "70518-3101", "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": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20210524", "listing_expiration_date": "20261231"}