Imatinib Mesylate Tablet
NDC Package 0832-0533-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Imatinib Mesylate tablets is a medication used to treat certain types of cancer (such as acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors, and myelodysplastic/myeloproliferative diseases). This formulation utilizes a tablet delivery system. Marketed by Upsher-smith Laboratories, Llc, this product is identified by NDC 0832-0533 and is authorized under FDA application ANDA212135.

Identification & Billing

NDC Package Code
0832-0533-03
Package Description
30 TABLET in 1 BOTTLE
Product Code
0832-0533
11-Digit Billing Format
00832053303
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Imatinib Mesylate
Non-Proprietary Name
Imatinib Mesylate
Substance Name
Imatinib Mesylate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
IMATINIB MESYLATE 400 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat certain types of cancer (such as acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors, and myelodysplastic/myeloproliferative diseases). It works by slowing or stopping the growth of cancer cells. Imatinib may also be used to treat certain immune system disorders (such as aggressive systemic mastocytosis, hypereosinophilic syndrome).

Regulatory & Marketing

Labeler Name
Upsher-smith Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212135
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-17-2024
End Marketing Date
01-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J8999
Source: PDAC
PRESCRIPTION DRUG, ORAL, CHEMOTHERAPEUTIC, NOS
HCPCS Dosage 1 EA
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0832-0533-03 identifies a specific commercial package of 30 tablet in 1 bottle of Imatinib Mesylate, a human prescription drug labeled by Upsher-smith Laboratories, Llc. This tablet is formulated for oral use and contains imatinib mesylate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Upsher-smith Laboratories, Llc on May 17, 2024.

What are the primary indications for this medication?

This medication is used to treat certain types of cancer (such as acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors, and myelodysplastic/myeloproliferative diseases). It works by slowing or stopping the growth of cancer cells. Imatinib may also be used to treat certain immune system disorders (such as aggressive systemic mastocytosis, hypereosinophilic syndrome).

How is this Upsher-smith Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00832053303. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0832-0533-03
11-Digit CMS (5-4-2)
00832-0533-03

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.