Dasatinib

Orange BookUNIISPLATC L01EA

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

Identification

ManufacturerDr.Reddys Laboratories Inc

CountryUS (United States)

ATC codeL01EA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4359860330
30 TABLET, FILM COATED in 1 BOTTLE (43598-603-30)

Annotations

UNII (FDA Substance ID)

RBZ1571X5H

DASATINIB

RxCUI 475342

Orange Book

A213383

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": "43598-603_ce9ef276-e0b1-4bd7-1e16-06035ef595a8",
  "productndc": "43598-603",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213383",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Mar 3, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Mar 3, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "70MG",
        "product_no": "003",
        "approval_date": "Mar 3, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Mar 3, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Mar 3, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "140MG",
        "product_no": "006",
        "approval_date": "Mar 3, 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": "ANDA213383",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dasatinib",
  "start_marketing_date": "20250303",
  "active_numerator_strength": "100"
}

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