XIGDUO

Orange BookUNIISPLATC A10BK

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAstraZeneca Pharmaceuticals LP

CountryUS (United States)

ATC codeA10BK

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0310626060
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6260-60)
ndc11
0310626095
1 BLISTER PACK in 1 CARTON (0310-6260-95) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

887K2391VH

DAPAGLIFLOZIN PROPANEDIOL

RxCUI 1486966

Orange Book

N205649

ABABABABAB

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": {
    "ac8a0f7b-9f69-4495-abbc-3a47cd75a859": {
      "match": "brand_token",
      "title": "XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]",
      "spl_version": "38",
      "published_date": "2025-01-23"
    }
  },
  "productid": "0310-6260_a8717b28-9445-4292-9ac7-e979f378d9c8",
  "productndc": "0310-6260",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205649",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG;500MG",
        "product_no": "001",
        "approval_date": "Oct 29, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG;1GM",
        "product_no": "002",
        "approval_date": "Oct 29, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;500MG",
        "product_no": "003",
        "approval_date": "Oct 29, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;1GM",
        "product_no": "004",
        "approval_date": "Oct 29, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG;1GM",
        "product_no": "005",
        "approval_date": "Jul 28, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "XIGDUO",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA205649",
  "marketing_category": "NDA",
  "nonproprietary_name": "dapagliflozin and metformin hydrochloride",
  "start_marketing_date": "20141029",
  "active_numerator_strength": "5; 1000"
}

Related drugs

Other records sharing ATC code A10BK.

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