Intron A
NDC Package 0085-4352-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Intron A is a medication used to treat various cancers (e.g., leukemia, melanoma, AIDS-related Kaposi's sarcoma). Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0085-4352 and is authorized under FDA application BLA103132.

Identification & Billing

NDC Package Code
0085-4352-01
Package Description
1 KIT in 1 CARTON * 1.25 mL in 1 VIAL * 5 mL in 1 VIAL (0085-4346-01)
Product Code
11-Digit Billing Format
00085435201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Intron A
Dosage Form
-
Usage Information
This medication is used to treat various cancers (e.g., leukemia, melanoma, AIDS-related Kaposi's sarcoma). It is also used to treat virus infections (e.g., chronic hepatitis B, chronic hepatitis C, condylomata acuminata). This medication is the same as a protein that your body naturally produces (interferon). In the body, it is thought to work by affecting cell function/growth and the body's natural defenses (immune system) in many ways. Adding more interferon may help your body fight off cancer or virus infections.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
FDA Application #
BLA103132
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-11-2014
End Marketing Date
07-17-2022
Listing Expiration
07-17-2022
Exclude Flag
D
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 0085-4352-01 identifies a specific commercial package of 1 kit in 1 carton * 1.25 ml in 1 vial * 5 ml in 1 vial (0085-4346-01) of Intron A, labeled by Merck Sharp & Dohme Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Merck Sharp & Dohme Llc on August 11, 2014. The current certification is valid through July 17, 2022.

What are the primary indications for this medication?

This medication is used to treat various cancers (e.g., leukemia, melanoma, AIDS-related Kaposi's sarcoma). It is also used to treat virus infections (e.g., chronic hepatitis B, chronic hepatitis C, condylomata acuminata). This medication is the same as a protein that your body naturally produces (interferon). In the body, it is thought to work by affecting cell function/growth and the body's natural defenses (immune system) in many ways. Adding more interferon may help your body fight off cancer or virus infections.

How is this Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00085435201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
0085-4352-01
11-Digit CMS (5-4-2)
00085-4352-01

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