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United States · US · US:50458-940_3ce5755e-f0a3-692b-e063-6294a90a3c1f

INVOKAMET XR

Orange BookUNIISPLATC A10BK

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

Identification

ManufacturerJanssen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BK
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5045894001
    60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-940-01)

Annotations

UNII (FDA Substance ID)
0SAC974Z85
CANAGLIFLOZIN
RxCUI 1373458
Orange Book
N205879
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0SAC974Z85",
    "rxcui": "1373458",
    "inchikey": "VHOFTEAWFCUTOS-TUGBYPPCSA-N",
    "display_name": "CANAGLIFLOZIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6868666b-c25e-40d1-9d1f-306bbe9390c1": {
      "match": "brand_token",
      "title": "INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED INVOKAMET XR (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]",
      "spl_version": "31",
      "published_date": "2025-08-25"
    }
  },
  "productid": "50458-940_3ce5755e-f0a3-692b-e063-6294a90a3c1f",
  "productndc": "50458-940",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205879",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG;500MG",
        "product_no": "001",
        "approval_date": "Sep 20, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG;1GM",
        "product_no": "002",
        "approval_date": "Sep 20, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "150MG;500MG",
        "product_no": "003",
        "approval_date": "Sep 20, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG;1GM",
        "product_no": "004",
        "approval_date": "Sep 20, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "INVOKAMET XR",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA205879",
  "marketing_category": "NDA",
  "nonproprietary_name": "canagliflozin and metformin hydrochloride",
  "start_marketing_date": "20160920",
  "active_numerator_strength": "50; 500"
}

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