dapagliflozin and metformin hydrochloride

Orange BookUNIISPLATC A10BK

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

Identification

ManufacturerPrasco Laboratories

CountryUS (United States)

ATC codeA10BK

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6699336160
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-361-60)

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": {
    "52a778e7-6044-2049-e063-6294a90aa0b7": {
      "match": "brand_token",
      "title": "DAPAGLIFLOZIN TABLET, FILM COATED [AVKARE]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "66993-361_8954a9fe-fbb8-4d24-949a-85ae4bfb7ba5",
  "productndc": "66993-361",
  "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": "dapagliflozin and metformin hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA205649",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "dapagliflozin and metformin hydrochloride",
  "start_marketing_date": "20240103",
  "active_numerator_strength": "5; 1000"
}

Related drugs

Other records sharing ATC code A10BK.

Access this data programmatically

Query dapagliflozin and metformin hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs