R-gene Injection, Solution
NDC Package 0009-0436-01

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

Package Information

R-gene (arginine hydrochloride) injection is r-Gene 10 is indicated as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can be of diagnostic usefulness. This formulation utilizes a injection, solution delivery system. Marketed by Pharmacia & Upjohn Company Llc, this product is identified by NDC 0009-0436 and is authorized under FDA application NDA016931.

Identification & Billing

NDC Package Code
0009-0436-01
Package Description
1 CONTAINER in 1 CARTON / 300 mL in 1 CONTAINER
Product Code
0009-0436
11-Digit Billing Format
00009043601
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
R-gene
Non-Proprietary Name
Arginine Hydrochloride
Substance Name
Arginine Hydrochloride
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ARGININE HYDROCHLORIDE 10 g/100mL
Usage Information
R-Gene 10 is indicated as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can be of diagnostic usefulness. It can be used as a diagnostic aid in such conditions as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism and problems of growth and stature.If the insulin hypoglycemia test has indicated a deficiency of pituitary reserve for HGH, a test with R-Gene 10 is advisable to confirm the negative response. This can be done after a waiting period of one day. As patients may not respond to R-Gene 10 (Arginine Hydrochloride Injection, USP) during the first test, the unresponsive patient should be tested again to confirm the negative result. A second test can be performed after a waiting period of one day. Some patients who respond to R-Gene 10 do not respond to insulin and vice versa. The rate of false positive responses for R-Gene 10 is approximately 32%, and the rate of false negatives is approximately 27%.

Regulatory & Marketing

Labeler Name
Pharmacia & Upjohn Company Llc
Product Type
Human Prescription Drug
FDA Application #
NDA016931
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-15-1976
Listing Expiration
12-31-2026
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 0009-0436-01 identifies a specific commercial package of 1 container in 1 carton / 300 ml in 1 container of R-gene, a human prescription drug labeled by Pharmacia & Upjohn Company Llc. This injection, solution is formulated for intravenous use and contains arginine hydrochloride 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 Pharmacia & Upjohn Company Llc on June 15, 1976. The current certification is valid through December 31, 2026.

How is this Pharmacia & Upjohn Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00009043601. 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 (4-4-2)
0009-0436-01
11-Digit CMS (5-4-2)
00009-0436-01

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