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United States · US · US:0006-5374_1981063d-b592-4847-ac6d-ba85722bd1d2

SEGLUROMET

Orange BookUNIISPLATC A10BK

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeA10BK
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    0006537403
    60 TABLET, FILM COATED in 1 BOTTLE (0006-5374-03)
  • ndc11
    0006537406
    180 TABLET, FILM COATED in 1 BOTTLE (0006-5374-06)
  • ndc11
    0006537407
    500 TABLET, FILM COATED in 1 BOTTLE (0006-5374-07)
  • ndc11
    0006537409
    2 BOTTLE in 1 CARTON (0006-5374-09) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-5374-08)

Annotations

UNII (FDA Substance ID)
MLU731K321
ERTUGLIFLOZIN PIDOLATE
RxCUI 1992674
Orange Book
N209806
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MLU731K321",
    "rxcui": "1992674",
    "inchikey": "YHIUPZFKHZTLSH-LXYIGGQGSA-N",
    "display_name": "ERTUGLIFLOZIN PIDOLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a6aeb99a-ce49-4125-90ce-642df3f1ebad": {
      "match": "brand_token",
      "title": "SEGLUROMET (ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]",
      "spl_version": "19",
      "published_date": "2025-01-13"
    }
  },
  "productid": "0006-5374_1981063d-b592-4847-ac6d-ba85722bd1d2",
  "productndc": "0006-5374",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209806",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2.5MG;500MG",
        "product_no": "001",
        "approval_date": "Dec 19, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2.5MG;1GM",
        "product_no": "002",
        "approval_date": "Dec 19, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "7.5MG;500MG",
        "product_no": "003",
        "approval_date": "Dec 19, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "7.5MG;1GM",
        "product_no": "004",
        "approval_date": "Dec 19, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ERTUGLIFLOZIN PIDOLATE; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "SEGLUROMET",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA209806",
  "marketing_category": "NDA",
  "nonproprietary_name": "ertugliflozin and metformin hydrochloride",
  "start_marketing_date": "20171219",
  "active_numerator_strength": "7.5; 1000"
}

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