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United States · US · US:42292-044_3ed7760b-0703-b47e-e063-6294a90a61f3

Imatinib Mesylate

Orange BookUNIISPLATC L01EA01

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

Identification

ManufacturerMylan Institutional Inc
CountryUS (United States)
ATC codeL01EA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4229204403
    30 BLISTER PACK in 1 CARTON (42292-044-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-044-01)

Annotations

UNII (FDA Substance ID)
8A1O1M485B
IMATINIB MESYLATE
RxCUI 284924
Orange Book
A204644
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": "42292-044_3ed7760b-0703-b47e-e063-6294a90a61f3",
  "productndc": "42292-044",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204644",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Jun 21, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "002",
        "approval_date": "Jun 21, 2017"
      }
    ],
    "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": "ANDA204644",
  "marketing_category": "ANDA",
  "nonproprietary_name": "imatinib",
  "start_marketing_date": "20170907",
  "active_numerator_strength": "400"
}

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