metformin hydrochloride

Generic: metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler granules pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 850 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-064
Product ID 70010-064_0266503f-0f1a-38e0-e063-6294a90a606f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090564
Listing Expiration 2026-12-31
Marketing Start 2019-06-26

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70010064
Hyphenated Format 70010-064

Supplemental Identifiers

RxCUI
861004 861007 861010
UNII
786Z46389E

Packaging Origin

Original Packager
true

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
  • 850 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70010-064-01)
  • 500 TABLET in 1 BOTTLE (70010-064-05)
  • 60 TABLET in 1 BOTTLE (70010-064-06)
  • 90 TABLET in 1 BOTTLE (70010-064-09)
  • 1000 TABLET in 1 BOTTLE (70010-064-10)
  • 1000 TABLET in 1 BOTTLE (70010-064-99)
source: ndc

Packages (6)

70010-064-01 100 TABLET in 1 BOTTLE (70010-064-01) 70010-064-05 500 TABLET in 1 BOTTLE (70010-064-05) 70010-064-06 60 TABLET in 1 BOTTLE (70010-064-06) 70010-064-09 90 TABLET in 1 BOTTLE (70010-064-09) 70010-064-10 1000 TABLET in 1 BOTTLE (70010-064-10) 70010-064-99 1000 TABLET in 1 BOTTLE (70010-064-99)

Ingredients (1)

metformin hydrochloride (850 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": "0266503f-0f1a-38e0-e063-6294a90a606f", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["2387a618-24d8-4813-aa83-9114edb35374"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70010-064-01)", "package_ndc": "70010-064-01", "marketing_start_date": "20190626"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70010-064-05)", "package_ndc": "70010-064-05", "marketing_start_date": "20190626"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (70010-064-06)", "package_ndc": "70010-064-06", "marketing_start_date": "20190626"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70010-064-09)", "package_ndc": "70010-064-09", "marketing_start_date": "20190626"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (70010-064-10)", "package_ndc": "70010-064-10", "marketing_start_date": "20190626"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (70010-064-99)", "package_ndc": "70010-064-99", "marketing_start_date": "20230809"}], "brand_name": "Metformin Hydrochloride", "product_id": "70010-064_0266503f-0f1a-38e0-e063-6294a90a606f", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "70010-064", "generic_name": "Metformin Hydrochloride", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "850 mg/1"}], "application_number": "ANDA090564", "marketing_category": "ANDA", "marketing_start_date": "20190626", "listing_expiration_date": "20261231"}