Ojjaara Tablet
NDC Package 81864-101-30

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

Package Information

Ojjaara (momelotinib) tablets is oJJAARA is indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia. This formulation utilizes a tablet delivery system. Marketed by Glaxosmithkline Llc, this product is identified by NDC 81864-101 and is authorized under FDA application NDA216873.

Identification & Billing

NDC Package Code
81864-101-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
81864-101
11-Digit Billing Format
81864010130
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 2665210 - momelotinib 100 MG Oral Tablet
  • RxCUI: 2665210 - momelotinib 100 MG (equivalent to 121.94 MG momelotinib dihydrochloride monohydrate) Oral Tablet
  • RxCUI: 2665216 - Ojjaara 100 MG Oral Tablet
  • RxCUI: 2665216 - momelotinib 100 MG Oral Tablet [Ojjaara]
  • RxCUI: 2665216 - Ojjaara 100 MG (equivalent to 121.94 MG momelotinib dihydrochloride monohydrate) Oral Tablet

Clinical Specifications

Proprietary Name
Ojjaara
Non-Proprietary Name
Momelotinib
Substance Name
Momelotinib Dihydrochloride Monohydrate
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)
MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE 200 mg/1
Pharmacologic Class
Usage Information
OJJAARA is indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Llc
Product Type
Human Prescription Drug
FDA Application #
NDA216873
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-15-2023
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81864-101-30 identifies a specific commercial package of 30 tablet in 1 bottle of Ojjaara, a human prescription drug labeled by Glaxosmithkline Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet is formulated for oral use and contains momelotinib dihydrochloride monohydrate 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 Glaxosmithkline Llc on September 15, 2023. The current certification is valid through December 31, 2027.

How is this Glaxosmithkline Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81864010130. 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 (5-3-2)
81864-101-30
11-Digit CMS (5-4-2)
81864-0101-30

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