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United States · US · US:0832-0532_47f6137e-e0ea-4ada-e063-6394a90a37b5

imatinib mesylate

Orange BookUNIISPLATC L01EA01

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeL01EA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0832053209
    90 TABLET in 1 BOTTLE (0832-0532-09)

Annotations

UNII (FDA Substance ID)
8A1O1M485B
IMATINIB MESYLATE
RxCUI 284924
Orange Book
A212135
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": "0832-0532_47f6137e-e0ea-4ada-e063-6394a90a37b5",
  "productndc": "0832-0532",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212135",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Jun 21, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "002",
        "approval_date": "Jun 21, 2022"
      }
    ],
    "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": "ANDA212135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "imatinib mesylate",
  "start_marketing_date": "20240517",
  "active_numerator_strength": "100"
}

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