IMATINIB MESYLATE

Orange BookUNIISPLATC L01EA01

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeL01EA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3172229690
90 TABLET, FILM COATED in 1 BOTTLE (31722-296-90)

Annotations

UNII (FDA Substance ID)

8A1O1M485B

IMATINIB MESYLATE

RxCUI 284924

Orange Book

A212975

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": "31722-296_4467e670-2d3a-9832-e063-6394a90a569b",
  "productndc": "31722-296",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212975",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Apr 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "002",
        "approval_date": "Apr 14, 2025"
      }
    ],
    "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": "ANDA212975",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IMATINIB MESYLATE",
  "start_marketing_date": "20250414",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code L01EA01.

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