SPRYCEL

Orange BookUNIISPLATC L01EA

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

Identification

ManufacturerE.R. Squibb & Sons, L.L.C.

CountryUS (United States)

ATC codeL01EA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0003052811
1 BOTTLE in 1 CARTON (0003-0528-11) / 60 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": {
    "4764f37b-c9e6-4ede-bcc2-8a03b7c521df": {
      "match": "brand_token",
      "title": "SPRYCEL (DASATINIB) TABLET [E.R. SQUIBB & SONS, L.L.C.]",
      "spl_version": "47",
      "published_date": "2024-08-15"
    }
  },
  "productid": "0003-0528_8f0a3afc-dde4-40d1-941d-68efd3f62adc",
  "productndc": "0003-0528",
  "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": "SPRYCEL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021986",
  "marketing_category": "NDA",
  "nonproprietary_name": "dasatinib",
  "start_marketing_date": "20060627",
  "active_numerator_strength": "50"
}

Related drugs

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