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United States · US · US:50458-541_3ce5755e-f0a3-692b-e063-6294a90a3c1f

INVOKAMET

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
    5045854160
    60 TABLET, FILM COATED in 1 BOTTLE (50458-541-60)

Annotations

UNII (FDA Substance ID)
0SAC974Z85
CANAGLIFLOZIN
RxCUI 1373458
Orange Book
N204353
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": "50458-541_3ce5755e-f0a3-692b-e063-6294a90a3c1f",
  "productndc": "50458-541",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204353",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG;500MG",
        "product_no": "001",
        "approval_date": "Aug 8, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG;1GM",
        "product_no": "002",
        "approval_date": "Aug 8, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "150MG;500MG",
        "product_no": "003",
        "approval_date": "Aug 8, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG;1GM",
        "product_no": "004",
        "approval_date": "Aug 8, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "INVOKAMET",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA204353",
  "marketing_category": "NDA",
  "nonproprietary_name": "canagliflozin and metformin hydrochloride",
  "start_marketing_date": "20140808",
  "active_numerator_strength": "50; 1000"
}

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