Riomet

Orange BookUNIIATC A10BA02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1063120601
118 mL in 1 BOTTLE (10631-206-01)
ndc11
1063120602
473 mL in 1 BOTTLE (10631-206-02)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

N021591

Raw payload (JSON)

{
  "unii": {
    "unii": "786Z46389E",
    "rxcui": "235743",
    "inchikey": "OETHQSJEHLVLGH-UHFFFAOYSA-N",
    "display_name": "METFORMIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "10631-206_8ed86d67-8a49-4334-82c4-1dbf6a489d3b",
  "productndc": "10631-206",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "021591",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Sep 11, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Riomet",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA021591",
  "marketing_category": "NDA",
  "nonproprietary_name": "Metformin Hydrochloride",
  "start_marketing_date": "20040104",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code A10BA02.

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