Quick answers
- What is Arginine hydrochloride used for?
- The FDA-approved label (R-Gene, Pharmacia & Upjohn Company LLC, April 2, 2024) says: “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 page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Arginine hydrochloride have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Arginine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Arginine hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Arginine hydrochloride?
- 1 company lists prescription products of Arginine hydrochloride in the FDA NDC Directory, including Pharmacia & Upjohn Company LLC.
What Arginine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: R-Gene, Pharmacia & Upjohn Company LLC, effective April 2, 2024. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | R-Gene |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Pharmacia & Upjohn Company LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA016931 R-GENE 10 | Pharmacia and Upjohn | February 28, 1973 | 16, latest January 17, 2010 2010: Labeling · 2003: Labeling · 2000: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 6accf33f-9841-4327-8923-93c42020ef12 |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA016931 |
| Active ingredients (FDA) | ARGININE HYDROCHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — R-Gene, Pharmacia & Upjohn Company LLC, effective April 2, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →