dapagliflozin and metformin hydrochloride

Orange BookUNIISPLATC A10BK

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeA10BK

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6787762105
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-621-05)
ndc11
6787762130
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-621-30)
ndc11
6787762138
10 BLISTER PACK in 1 CARTON (67877-621-38) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

1ULL0QJ8UC

DAPAGLIFLOZIN

RxCUI 1488564

Orange Book

A211563

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1ULL0QJ8UC",
    "rxcui": "1488564",
    "inchikey": "JVHXJTBJCFBINQ-ADAARDCZSA-N",
    "display_name": "DAPAGLIFLOZIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52a778e7-6044-2049-e063-6294a90aa0b7": {
      "match": "brand_token",
      "title": "DAPAGLIFLOZIN TABLET, FILM COATED [AVKARE]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "67877-621_a54a2b85-619a-4bb8-b3fa-dfe945a9008d",
  "productndc": "67877-621",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211563",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;500MG",
        "product_no": "001",
        "approval_date": "Apr 6, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;1GM",
        "product_no": "002",
        "approval_date": "Apr 6, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;500MG",
        "product_no": "003",
        "approval_date": "Apr 6, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;1GM",
        "product_no": "004",
        "approval_date": "Apr 6, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "dapagliflozin and metformin hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211563",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dapagliflozin and metformin hydrochloride",
  "start_marketing_date": "20260406",
  "active_numerator_strength": "10; 500"
}

Related drugs

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