Daklinza
NDC Package 0003-0213-01

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.

Daklinza is daclatasvir is used with another antiviral medication (sofosbuvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Marketed by E.r. Squibb & Sons, L.l.c., this product is identified by NDC 0003-0213 and is authorized under FDA application NDA206843.

Identification & Billing

NDC Package Code
0003-0213-01
Package Description
28 TABLET in 1 BOTTLE
Product Code
11-Digit Billing Format
00003021301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA

Clinical Specifications

Proprietary Name
Daklinza
Dosage Form
-
Usage Information
Daclatasvir is used with another antiviral medication (sofosbuvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Daclatasvir should never be used without sofosbuvir. Daclatasvir and sofosbuvir may also be used with another antiviral medication (ribavirin). These medications together reduce the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.

Regulatory & Marketing

Labeler Name
E.r. Squibb & Sons, L.l.c.
FDA Application #
NDA206843
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-27-2015
End Marketing Date
06-30-2020
Listing Expiration
06-30-2020
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 0003-0213-01 identifies a specific commercial package of 28 tablet in 1 bottle of Daklinza, labeled by E.r. Squibb & Sons, L.l.c.. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package. 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 E.r. Squibb & Sons, L.l.c. on July 27, 2015. The current certification is valid through June 30, 2020.

What are the primary indications for this medication?

Daclatasvir is used with another antiviral medication (sofosbuvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Daclatasvir should never be used without sofosbuvir. Daclatasvir and sofosbuvir may also be used with another antiviral medication (ribavirin). These medications together reduce the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.

How is this E.r. Squibb & Sons, L.l.c. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00003021301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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)
0003-0213-01
11-Digit CMS (5-4-2)
00003-0213-01

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