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United States · US · US:50090-5034_f8148180-4b45-4670-a46c-94171161f367

INVOKANA

Orange BookUNIISPLATC A10BK02

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA10BK02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009050340
    90 TABLET, FILM COATED in 1 BOTTLE (50090-5034-0)
  • ndc11
    5009050341
    30 TABLET, FILM COATED in 1 BOTTLE (50090-5034-1)

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": "50090-5034_f8148180-4b45-4670-a46c-94171161f367",
  "productndc": "50090-5034",
  "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": "100"
}

Related drugs

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