metformin hydrochloride

Generic: metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 850 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-759
Product ID 68382-759_cb5dfb45-8968-4a83-a807-d225b427b1cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203686
Listing Expiration 2026-12-31
Marketing Start 2014-12-09

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382759
Hyphenated Format 68382-759

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0368382759016
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 ANDA203686 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 850 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68382-759-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (68382-759-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68382-759-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68382-759-16)
  • 100 BLISTER PACK in 1 CARTON (68382-759-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-759-30)
source: ndc

Packages (5)

68382-759-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-759-01) 68382-759-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-759-05) 68382-759-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-759-10) 68382-759-16 90 TABLET, FILM COATED in 1 BOTTLE (68382-759-16) 68382-759-77 100 BLISTER PACK in 1 CARTON (68382-759-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-759-30)

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": "cb5dfb45-8968-4a83-a807-d225b427b1cb", "openfda": {"upc": ["0368382759016"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["c82a10fa-1e8e-46b6-890a-737de3f34ee1"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-759-01)", "package_ndc": "68382-759-01", "marketing_start_date": "20141209"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68382-759-05)", "package_ndc": "68382-759-05", "marketing_start_date": "20141209"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-759-10)", "package_ndc": "68382-759-10", "marketing_start_date": "20141209"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-759-16)", "package_ndc": "68382-759-16", "marketing_start_date": "20141209"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (68382-759-77)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-759-30)", "package_ndc": "68382-759-77", "marketing_start_date": "20141209"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "68382-759_cb5dfb45-8968-4a83-a807-d225b427b1cb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68382-759", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "850 mg/1"}], "application_number": "ANDA203686", "marketing_category": "ANDA", "marketing_start_date": "20141209", "listing_expiration_date": "20261231"}