metformin hydrochloride

Generic: metformin hydrochloride

Labeler: laurus labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler laurus labs limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 750 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-978
Product ID 42385-978_0e7b02cc-2ddc-4394-a80c-128e6452d697
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217631
Listing Expiration 2026-12-31
Marketing Start 2023-10-06

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42385978
Hyphenated Format 42385-978

Supplemental Identifiers

RxCUI
860975 860981
UPC
0342385978179
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 ANDA217631 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-05)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-11)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-18)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-30)
  • 15 BLISTER PACK in 1 CARTON (42385-978-72) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-90)
source: ndc

Packages (7)

42385-978-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-01) 42385-978-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-05) 42385-978-11 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-11) 42385-978-18 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-18) 42385-978-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-30) 42385-978-72 15 BLISTER PACK in 1 CARTON (42385-978-72) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 42385-978-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-90)

Ingredients (1)

metformin hydrochloride (750 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": "0e7b02cc-2ddc-4394-a80c-128e6452d697", "openfda": {"upc": ["0342385978179"], "unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["0e7b02cc-2ddc-4394-a80c-128e6452d697"], "manufacturer_name": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-01)", "package_ndc": "42385-978-01", "marketing_start_date": "20231006"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-05)", "package_ndc": "42385-978-05", "marketing_start_date": "20231006"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-11)", "package_ndc": "42385-978-11", "marketing_start_date": "20231006"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-18)", "package_ndc": "42385-978-18", "marketing_start_date": "20231006"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-30)", "package_ndc": "42385-978-30", "marketing_start_date": "20231006"}, {"sample": false, "description": "15 BLISTER PACK in 1 CARTON (42385-978-72)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "42385-978-72", "marketing_start_date": "20231006"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-90)", "package_ndc": "42385-978-90", "marketing_start_date": "20231006"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "42385-978_0e7b02cc-2ddc-4394-a80c-128e6452d697", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "42385-978", "generic_name": "METFORMIN HYDROCHLORIDE", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "750 mg/1"}], "application_number": "ANDA217631", "marketing_category": "ANDA", "marketing_start_date": "20231006", "listing_expiration_date": "20261231"}