metformin hydrochloride

Generic: metformin hydrochloride

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
UNICHEM PHARMACEUTICALS (USA), INC.

Identifiers & Regulatory

Product NDC 76385-128
Product ID 76385-128_4658e557-69fa-4884-904c-fae9fe8012be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207427
Listing Expiration 2027-12-31
Marketing Start 2018-07-17

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76385128
Hyphenated Format 76385-128

Supplemental Identifiers

RxCUI
860975 860981
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 ANDA207427 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-01)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-10)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-50)
source: ndc

Packages (3)

76385-128-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-01) 76385-128-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-10) 76385-128-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-50)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Metformin hydrochloride, Metformin hydrochloride ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4658e557-69fa-4884-904c-fae9fe8012be", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["93c8deae-3103-4cbf-a5d1-fe0d37e76df8"], "manufacturer_name": ["UNICHEM PHARMACEUTICALS (USA), INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-01)", "package_ndc": "76385-128-01", "marketing_start_date": "20180717"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-10)", "package_ndc": "76385-128-10", "marketing_start_date": "20180717"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-50)", "package_ndc": "76385-128-50", "marketing_start_date": "20190725"}], "brand_name": "Metformin hydrochloride", "product_id": "76385-128_4658e557-69fa-4884-904c-fae9fe8012be", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "76385-128", "generic_name": "Metformin hydrochloride", "labeler_name": "UNICHEM PHARMACEUTICALS (USA), INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA207427", "marketing_category": "ANDA", "marketing_start_date": "20180717", "listing_expiration_date": "20271231"}