PROFESSIONAL RESOURCES

This section is designed to provide important information regarding reimbursement, the IMBRUVICA® Dose Exchange Program, specialty pharmacies, and other product information.

Such information may be subject to continual change and interpretation. It is provided for informational purposes only and does not guarantee coverage or payment. It is always the provider's responsibility to determine and submit appropriate codes and modifiers based on the services rendered and the provider's medical judgment. Providers should contact the payer for coding and billing guidance.

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NDC Numbers for IMBRUVICA® (ibrutinib)

Understanding NDC Numbers

Medications regulated under section 510 of the US Federal Food, Drug, and Cosmetic Act are assigned a unique, 3-segment number known as the National Drug Code (NDC).

Imbruvica® labeler code 57962, product code (0)420, and package code 28Imbruvica® labeler code 57962, product code (0)420, and package code 28
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NDC numbers for IMBRUVICA®1
10-digit NDC11-digit NDCDescription
57962-420-2857962-0420-28Carton of 28 tablets
420 mg per tablet
57962-280-2857962-0280-28Carton of 28 tablets
280 mg per tablet
57962-014-2857962-0014-28Carton of 28 tablets
140 mg per tablet
57962-140-0957962-0140-09Bottle of 90 capsules
140 mg capsules
57962-140-1257962-0140-12Bottle of 120 capsules
140 mg capsules
57962-070-2857962-0070-28Bottle of 28 capsules
70 mg capsules
57962-007-1257962-0007-12Bottle of 108 mL
70 mg/mL oral suspension

Note: The red zero converts the 10-digit NDC to the 11-digit NDC. The red is for emphasis and not for billing purposes.

PLEASE NOTE: Some payers may require that each NDC number be listed on the claim. Payer requirements regarding the use of the 10- or 11-digit NDC may vary. Electronic data exchange generally requires use of the 11-digit NDC, as listed above.

Additional Product Information1

How supplied:

IMBRUVICA® capsules are supplied in white HDPE bottles with a child-resistant closure. Capsules are supplied in 2 dosage strengths:

  • Yellow opaque capsules marked with “ibr 70 mg” in black ink
  • White opaque capsules marked with “ibr 140 mg” in black ink


IMBRUVICA® tablets are available in a carton of 1 folded blister card containing two 14-count blister strips for a total of 28 tablets. Tablets are supplied in 3 dosage strengths:

  • Yellow-green to green round tablets debossed with “ibr“ on one side and “140” on the other side
  • Purple oblong tablets debossed with “ibr” on one side and “280“ on the other side
  • Yellow-green to green oblong tablets debossed with “ibr” on one side and “420“ on the other side

The IMBRUVICA® (ibrutinib) oral suspension is a white to off-white suspension supplied as 108 mL in a 150 mL amber glass bottle with a pre-inserted bottle adapter and a child-resistant closure. Each mL contains 70 mg of ibrutinib. The oral suspension bottle is provided in a carton with two 3 mL reusable oral dosing syringes: NDC 57962-007-12.


Storage and handling:

Store IMBRUVICA® in its original packaging at room temperature, 20 °C to 25 °C (68 °F to 77 °F). Excursions are permitted between 15 °C and 30 °C (59 °F to 86 °F).

Store the oral suspension bottle at 2°C to 25°C (36°F to 77°F). Do not freeze. Dispense in original sealed container. Do not use if the carton seal is broken or missing.

Discard any unused IMBRUVICA® oral suspension remaining 60 days after first opening the bottle.

Abbreviations

HDPE=high-density polyethylene, NDC=National Drug Code.

Reference

1IMBRUVICA® (ibrutinib) Prescribing Information.