Dasatinib

Orange BookUNIISPLATC L01EA

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeL01EA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7074821007
1 BOTTLE in 1 CARTON (70748-210-07) / 60 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

RBZ1571X5H

DASATINIB

RxCUI 475342

Orange Book

A214350

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": "70748-210_79f45560-3318-42e3-8be6-fac133dca745",
  "productndc": "70748-210",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214350",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Aug 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Aug 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "70MG",
        "product_no": "003",
        "approval_date": "Aug 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Aug 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Aug 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "140MG",
        "product_no": "006",
        "approval_date": "Aug 25, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DASATINIB",
  "proprietary_name": "Dasatinib",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214350",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dasatinib",
  "start_marketing_date": "20260130",
  "active_numerator_strength": "70"
}

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