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United States · US · US:0093-7630_0cdf555d-a2ab-481a-9414-9aea7884298e

Imatinib Mesylate

Orange BookUNIISPLATC L01EA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeL01EA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0093763056
    30 TABLET, FILM COATED in 1 BOTTLE (0093-7630-56)

Annotations

UNII (FDA Substance ID)
8A1O1M485B
IMATINIB MESYLATE
RxCUI 284924
Orange Book
A204285
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "8A1O1M485B",
    "rxcui": "284924",
    "inchikey": "YLMAHDNUQAMNNX-UHFFFAOYSA-N",
    "display_name": "IMATINIB MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c0611fc0-b217-4988-acd4-b8c629ce489b": {
      "match": "brand_token",
      "title": "IMATINIB MESYLATE TABLET, FILM COATED [BLUEPOINT LABORATORIES]",
      "spl_version": "4",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0093-7630_0cdf555d-a2ab-481a-9414-9aea7884298e",
  "productndc": "0093-7630",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204285",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Aug 4, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "002",
        "approval_date": "Aug 4, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IMATINIB MESYLATE",
  "proprietary_name": "Imatinib Mesylate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204285",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Imatinib Mesylate",
  "start_marketing_date": "20160804",
  "active_numerator_strength": "400"
}

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