NDC Package 0338-0326-01 Recothrom

Thrombin Topical Recombinant Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

0338-0326-01

Package Description:

1 KIT in 1 KIT * 20 mL in 1 VIAL (0338-0328-01) * 20 mL in 1 SYRINGE

Product Code:

0338-0326

Proprietary Name:

Recothrom

Non-Proprietary Name:

Thrombin Topical Recombinant

Usage Information:

RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.

11-Digit NDC Billing Format:

00338032601

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

RxCUI: 1367418 - thrombin alfa 1000 UNT in 1 ML Topical Solution

RxCUI: 1367418 - thrombin alfa 1000 UNT/ML Topical Solution

RxCUI: 1367418 - alfa-thrombin 1000 UNT/ML Topical Solution

RxCUI: 1367418 - thrombin alfa 1000 UNT per 1 ML Topical Solution

RxCUI: 1367418 - thrombin alfa 20,000 UNT per 20 ML Topical Solution

Product Type:

Human Prescription Drug

Labeler Name:

Baxter Healthcare Corporation

Dosage Form:

Kit - A packaged collection of related material.

Sample Package:

FDA Application Number:

BLA125248

Marketing Category:

BLA - A product marketed under an approved Biologic License Application.

Start Marketing Date:

06-09-2008

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

0338 - Baxter Healthcare Corporation
- 0338-0326 - Recothrom
  - 0338-0326-01 - 1 KIT in 1 KIT * 20 mL in 1 VIAL (0338-0328-01) * 20 mL in 1 SYRINGE

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 disclaimer below.

Frequently Asked Questions

What is NDC 0338-0326-01?

The NDC Packaged Code 0338-0326-01 is assigned to a package of 1 kit in 1 kit * 20 ml in 1 vial (0338-0328-01) * 20 ml in 1 syringe of Recothrom, a human prescription drug labeled by Baxter Healthcare Corporation. The product's dosage form is kit and is administered via form.

Is NDC 0338-0326 included in the NDC Directory?

Yes, Recothrom with product code 0338-0326 is active and included in the NDC Directory. The product was first marketed by Baxter Healthcare Corporation on June 09, 2008 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0338-0326-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

What is the 11-digit format for NDC 0338-0326-01?

The 11-digit format is 00338032601. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0338-0326-01	5-4-2	00338-0326-01

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