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  5. NDC Package Code: 0009-0436-01 R-gene

NDC Package 0009-0436-01 R-gene

Arginine Hydrochloride Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
0009-0436-01
Package Description:
1 CONTAINER in 1 CARTON / 300 mL in 1 CONTAINER
Product Code:
0009-0436
Proprietary Name:
R-gene
Non-Proprietary Name:
Arginine Hydrochloride
Substance Name:
Arginine Hydrochloride
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%.
11-Digit NDC Billing Format:
00009043601
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type:
Human Prescription Drug
Labeler Name:
Pharmacia & Upjohn Company Llc
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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • ARGININE HYDROCHLORIDE 10 g/100mL
    • Sample Package:
    No
    FDA Application Number:
    NDA016931
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-15-1976
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 0009-0436-01?

    The NDC Packaged Code 0009-0436-01 is assigned to a 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. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 0009-0436 included in the NDC Directory?

    Yes, R-gene with product code 0009-0436 is active and included in the NDC Directory. The product was first marketed by Pharmacia & Upjohn Company Llc on June 15, 1976 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 0009-0436-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0009-0436-01?

    The 11-digit format is 00009043601. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20009-0436-015-4-200009-0436-01