Follistim Aq Injection, Solution
NDC Package 78206-129-01

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

Package Information

Follistim Aq (follitropin) injection is follistim® AQ Cartridge (follitropin beta) injection, is indicated:In Women for:. This formulation utilizes a injection, solution delivery system. Marketed by Organon Llc, this product is identified by NDC 78206-129 and is authorized under FDA application BLA021211.

Identification & Billing

NDC Package Code
78206-129-01
Package Description
1 KIT in 1 CARTON / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-99)
Product Code
78206-129
11-Digit Billing Format
78206012901
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Follistim Aq
Non-Proprietary Name
Follitropin
Substance Name
Follitropin
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
FOLLITROPIN 300 [iU]/.36mL
Pharmacologic Class
Usage Information
Follistim® AQ Cartridge (follitropin beta) injection, is indicated:In Women for:

Regulatory & Marketing

Labeler Name
Organon Llc
Product Type
Human Prescription Drug
FDA Application #
BLA021211
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-24-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (78206-129). Click a package code to view its specific billing and regulatory data.

78206-129-59
1 KIT in 1 CARTON / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-58)

* 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 78206-129-01 identifies a specific commercial package of 1 kit in 1 carton / 1 cartridge in 1 kit / .36 ml in 1 cartridge (78206-129-99) of Follistim Aq, a human prescription drug labeled by Organon Llc. This injection, solution is formulated for subcutaneous use and contains follitropin 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 Organon Llc on July 24, 2023. The current certification is valid through December 31, 2027.

How is this Organon Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78206012901. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
78206-129-01
11-Digit CMS (5-4-2)
78206-0129-01

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