Dasatinib

Orange BookUNIISPLATC L01EA

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

Identification

ManufacturerPrasco Laboratories

CountryUS (United States)

ATC codeL01EA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6699323730
1 BOTTLE in 1 CARTON (66993-237-30) / 30 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

RBZ1571X5H

DASATINIB

RxCUI 475342

Orange Book

N021986

ABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "RBZ1571X5H",
    "rxcui": "475342",
    "inchikey": "XHXFZZNHDVTMLI-UHFFFAOYSA-N",
    "display_name": "DASATINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f9b79d54-9bee-4c93-9c87-f3e65d91f146": {
      "match": "brand_token",
      "title": "DASATINIB TABLET, FILM COATED [NORTHSTAR RXLLC]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "66993-237_19048218-75dd-45fc-8e6e-fc660d861fb7",
  "productndc": "66993-237",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021986",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jun 28, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jun 28, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "70MG",
        "product_no": "003",
        "approval_date": "Jun 28, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "May 30, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "005",
        "approval_date": "Oct 28, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "140MG",
        "product_no": "006",
        "approval_date": "Oct 28, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DASATINIB",
  "proprietary_name": "Dasatinib",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021986",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "dasatinib",
  "start_marketing_date": "20240903",
  "active_numerator_strength": "100"
}

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