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United States · US · US:50458-141_30ca5702-272c-7528-e063-6294a90abbc1

INVOKANA

Orange BookUNIISPLATC A10BK02

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

Identification

ManufacturerJanssen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BK02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    5045814101
    5 TABLET, FILM COATED in 1 BOTTLE (50458-141-01)
  • ndc11
    5045814110
    10 BLISTER PACK in 1 CARTON (50458-141-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5045814130
    30 TABLET, FILM COATED in 1 BOTTLE (50458-141-30)
  • ndc11
    5045814150
    500 TABLET, FILM COATED in 1 BOTTLE (50458-141-50)
  • ndc11
    5045814190
    90 TABLET, FILM COATED in 1 BOTTLE (50458-141-90)

Annotations

UNII (FDA Substance ID)
0SAC974Z85
CANAGLIFLOZIN
RxCUI 1373458
Orange Book
N204042
ABAB
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": {
    "5f76e16f-0c24-454a-81af-4080b312c940": {
      "match": "brand_token",
      "title": "INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
      "spl_version": "14",
      "published_date": "2026-02-23"
    }
  },
  "productid": "50458-141_30ca5702-272c-7528-e063-6294a90abbc1",
  "productndc": "50458-141",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204042",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Mar 29, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Mar 29, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CANAGLIFLOZIN",
  "proprietary_name": "INVOKANA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204042",
  "marketing_category": "NDA",
  "nonproprietary_name": "canagliflozin",
  "start_marketing_date": "20130329",
  "active_numerator_strength": "300"
}

Related drugs

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