Human Papillomavirus Type 11 L1 Protein Adsorbed Liquid
NDC Package 68594-008-99

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Human Papillomavirus Type 11 L1 Protein Adsorbed liquids is a vaccine. This formulation utilizes a liquid delivery system. Marketed by Boehringer Ingelheim Rcv Gmbh & Co Kg, this product is identified by NDC 68594-008.

Identification & Billing

NDC Package Code
68594-008-99
Package Description
45000 mL in 1 BOTTLE, GLASS
Product Code
68594-008
11-Digit Billing Format
68594000899

Clinical Specifications

Proprietary Name
Human Papillomavirus Type 11 L1 Protein Adsorbed
Non-Proprietary Name
Human Papillomavirus Type 11 L1 Protein Adsorbed
Substance Name
Human Papillomavirus Type 11 L1 Capsid Protein Antigen
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN .32 mg/mL

Regulatory & Marketing

Labeler Name
Boehringer Ingelheim Rcv Gmbh & Co Kg
Product Type
Vaccine
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-22-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 68594-008-99 identifies a specific commercial package of 45000 ml in 1 bottle, glass of Human Papillomavirus Type 11 L1 Protein Adsorbed (UNFINISHED drug), a vaccine label labeled by Boehringer Ingelheim Rcv Gmbh & Co Kg. This liquid is formulated for use and contains human papillomavirus type 11 l1 capsid protein antigen 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 Boehringer Ingelheim Rcv Gmbh & Co Kg on January 22, 2024. The current certification is valid through December 31, 2026.

How is this Boehringer Ingelheim Rcv Gmbh & Co Kg product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68594000899. 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)
68594-008-99
11-Digit CMS (5-4-2)
68594-0008-99

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