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, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 850 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-948
Product ID 42385-948_d2500c46-4274-4a87-b4bf-3a3bfc361630
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209882
Listing Expiration 2026-12-31
Marketing Start 2021-05-17

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42385948
Hyphenated Format 42385-948

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0342385949605 0342385948905 0342385949100 0342385948103
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 ANDA209882 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 850 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42385-948-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (42385-948-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (42385-948-11)
  • 180 TABLET, FILM COATED in 1 BOTTLE (42385-948-18)
  • 10 BLISTER PACK in 1 CARTON (42385-948-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 90 TABLET, FILM COATED in 1 BOTTLE (42385-948-90)
source: ndc

Packages (6)

42385-948-01 100 TABLET, FILM COATED in 1 BOTTLE (42385-948-01) 42385-948-05 500 TABLET, FILM COATED in 1 BOTTLE (42385-948-05) 42385-948-11 1000 TABLET, FILM COATED in 1 BOTTLE (42385-948-11) 42385-948-18 180 TABLET, FILM COATED in 1 BOTTLE (42385-948-18) 42385-948-19 10 BLISTER PACK in 1 CARTON (42385-948-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK 42385-948-90 90 TABLET, FILM COATED in 1 BOTTLE (42385-948-90)

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": "d2500c46-4274-4a87-b4bf-3a3bfc361630", "openfda": {"upc": ["0342385949605", "0342385948905", "0342385949100", "0342385948103"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949"], "manufacturer_name": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42385-948-01)", "package_ndc": "42385-948-01", "marketing_start_date": "20210720"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42385-948-05)", "package_ndc": "42385-948-05", "marketing_start_date": "20210720"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (42385-948-11)", "package_ndc": "42385-948-11", "marketing_start_date": "20210517"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (42385-948-18)", "package_ndc": "42385-948-18", "marketing_start_date": "20210720"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (42385-948-19)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "42385-948-19", "marketing_start_date": "20210517"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42385-948-90)", "package_ndc": "42385-948-90", "marketing_start_date": "20210517"}], "brand_name": "Metformin Hydrochloride", "product_id": "42385-948_d2500c46-4274-4a87-b4bf-3a3bfc361630", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "42385-948", "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": "850 mg/1"}], "application_number": "ANDA209882", "marketing_category": "ANDA", "marketing_start_date": "20210517", "listing_expiration_date": "20261231"}