Adenovirus Type 4 And Type 7 Vaccine, Live Kit
NDC Package 51285-138-50

11-digit billing NDC: 51285013850 · Billing unit: EA · 1 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Adenovirus Type 4 And Type 7 Vaccine, Live kits is adenovirus Type 4 and Type 7 Vaccine, Live, Oral is a vaccine indicated for active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7. This formulation utilizes a kit delivery system. Marketed by Teva Women's Health Llc, this product is identified by NDC 51285-138 and is authorized under FDA application BLA125296.

Identification & Billing

NDC Package Code
51285-138-50
Package Description
1 KIT in 1 CARTON * 100 TABLET, COATED in 1 BOTTLE (51285-175-02) * 100 TABLET, COATED in 1 BOTTLE (51285-174-02)
Product Code
51285-138
11-Digit Billing Format
51285013850
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1099936 - adenovirus type 4 vaccine, live 32,000 TCID50 Delayed Release Oral Tablet
  • RxCUI: 1099936 - adenovirus type 4 vaccine live 32000 UNT Delayed Release Oral Tablet
  • RxCUI: 1099940 - adenovirus type 7 vaccine, live 32,000 TCID50 Delayed Release Oral Tablet
  • RxCUI: 1099940 - adenovirus type 7 vaccine live 32000 UNT Delayed Release Oral Tablet
  • RxCUI: 1099941 - {100 (adenovirus type 4 vaccine live 32000 UNT Delayed Release Oral Tablet) / 100 (adenovirus type 7 vaccine live 32000 UNT Delayed Release Oral Tablet) } Pack

Clinical Specifications

Proprietary Name
Adenovirus Type 4 And Type 7 Vaccine, Live
Non-Proprietary Name
Adenovirus Type 4 And Type 7 Vaccine, Live
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is a vaccine indicated for active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is approved for use in military populations 17 through 50 years of age.

Regulatory & Marketing

Labeler Name
Teva Women's Health Llc
Product Type
Vaccine
FDA Application #
BLA125296
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-16-2011
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 51285-138-50 identifies a specific commercial package of 1 kit in 1 carton * 100 tablet, coated in 1 bottle (51285-175-02) * 100 tablet, coated in 1 bottle (51285-174-02) of Adenovirus Type 4 And Type 7 Vaccine, Live, a vaccine label labeled by Teva Women's Health Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This kit is formulated for use and contains 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 Teva Women's Health Llc on September 16, 2011. The current certification is valid through December 31, 2027.

How is this Teva Women's Health Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51285013850. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
51285-138-50
11-Digit CMS (5-4-2)
51285-0138-50

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