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, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1951
Product ID 70518-1951_498a95ea-832f-a15d-e063-6394a90a7026
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203769
Listing Expiration 2027-12-31
Marketing Start 2019-03-12

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181951
Hyphenated Format 70518-1951

Supplemental Identifiers

RxCUI
861007
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 ANDA203769 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1951-2)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1951-3)
source: ndc

Packages (2)

70518-1951-2 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1951-2) 70518-1951-3 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1951-3)

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": "498a95ea-832f-a15d-e063-6394a90a7026", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861007"], "spl_set_id": ["13235d8e-ac3a-45b4-9c5d-9a9012951dfe"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1951-2)", "package_ndc": "70518-1951-2", "marketing_start_date": "20250601"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1951-3)", "package_ndc": "70518-1951-3", "marketing_start_date": "20251028"}], "brand_name": "Metformin Hydrochloride", "product_id": "70518-1951_498a95ea-832f-a15d-e063-6394a90a7026", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "70518-1951", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA203769", "marketing_category": "ANDA", "marketing_start_date": "20190312", "listing_expiration_date": "20271231"}