riomet

Generic: metformin hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name riomet
Generic Name metformin hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/5mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 10631-238
Product ID 10631-238_8ed86d67-8a49-4334-82c4-1dbf6a489d3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021591
Listing Expiration 2026-12-31
Marketing Start 2004-01-04

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10631238
Hyphenated Format 10631-238

Supplemental Identifiers

RxCUI
861025 861027
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 riomet (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number NDA021591 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (10631-238-01)
  • 473 mL in 1 BOTTLE (10631-238-02)
source: ndc

Packages (2)

10631-238-01 118 mL in 1 BOTTLE (10631-238-01) 10631-238-02 473 mL in 1 BOTTLE (10631-238-02)

Ingredients (1)

metformin hydrochloride (500 mg/5mL)

Linked Drug Pages (1)

Riomet ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8ed86d67-8a49-4334-82c4-1dbf6a489d3b", "openfda": {"unii": ["786Z46389E"], "rxcui": ["861025", "861027"], "spl_set_id": ["05d4df4b-dfe8-4828-b423-a3d4f2c4114a"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (10631-238-01)", "package_ndc": "10631-238-01", "marketing_start_date": "20040104"}, {"sample": false, "description": "473 mL in 1 BOTTLE (10631-238-02)", "package_ndc": "10631-238-02", "marketing_start_date": "20040104"}], "brand_name": "Riomet", "product_id": "10631-238_8ed86d67-8a49-4334-82c4-1dbf6a489d3b", "dosage_form": "SOLUTION", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "10631-238", "generic_name": "Metformin Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Riomet", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/5mL"}], "application_number": "NDA021591", "marketing_category": "NDA", "marketing_start_date": "20040104", "listing_expiration_date": "20261231"}