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United States · US · US:0310-6210_10d25358-e717-4294-9ec1-c73b8f45009d

FARXIGA

Orange BookUNIISPLATC A10BK

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

Identification

ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeA10BK
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    0310621030
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6210-30)
  • ndc11
    0310621039
    3 BLISTER PACK in 1 CARTON (0310-6210-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0310621090
    90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6210-90)
  • ndc11
    0310621095
    1 BLISTER PACK in 1 CARTON (0310-6210-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
887K2391VH
DAPAGLIFLOZIN PROPANEDIOL
RxCUI 1486966
Orange Book
N202293
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "887K2391VH",
    "rxcui": "1486966",
    "inchikey": "GOADIQFWSVMMRJ-UPGAGZFNSA-N",
    "display_name": "DAPAGLIFLOZIN PROPANEDIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "72ad22ae-efe6-4cd6-a302-98aaee423d69": {
      "match": "brand_token",
      "title": "FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]",
      "spl_version": "45",
      "published_date": "2026-04-30"
    }
  },
  "productid": "0310-6210_10d25358-e717-4294-9ec1-c73b8f45009d",
  "productndc": "0310-6210",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202293",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jan 8, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jan 8, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAPAGLIFLOZIN PROPANEDIOL",
  "proprietary_name": "FARXIGA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202293",
  "marketing_category": "NDA",
  "nonproprietary_name": "DAPAGLIFLOZIN",
  "start_marketing_date": "20080114",
  "active_numerator_strength": "10"
}

Related drugs

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