metformin hydrochloride

Generic: metformin

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

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6001
Product ID 0378-6001_40fb3426-10f9-4c69-a43a-4a72d143b350
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200690
Listing Expiration 2026-12-31
Marketing Start 2016-08-23

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03786001
Hyphenated Format 0378-6001

Supplemental Identifiers

RxCUI
1807894 1807917
UPC
0303786002917 0303786001910
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 (source: ndc)
Application Number ANDA200690 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91)
source: ndc

Packages (1)

0378-6001-91 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91)

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": "40fb3426-10f9-4c69-a43a-4a72d143b350", "openfda": {"upc": ["0303786002917", "0303786001910"], "unii": ["786Z46389E"], "rxcui": ["1807894", "1807917"], "spl_set_id": ["7e41818c-60e9-4bcf-9586-7bb8d33d5e89"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91)", "package_ndc": "0378-6001-91", "marketing_start_date": "20160823"}], "brand_name": "Metformin Hydrochloride", "product_id": "0378-6001_40fb3426-10f9-4c69-a43a-4a72d143b350", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "0378-6001", "generic_name": "metformin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA200690", "marketing_category": "ANDA", "marketing_start_date": "20160823", "listing_expiration_date": "20261231"}