Prescription medicine
Arginine Brand names: R-Gene
Arginine (R-Gene) is a prescription medicine with an FDA approval on record since 1973. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the arginine FDA label on DailyMed (effective April 2, 2024, Pharmacia & Upjohn Company LLC); the NDA 16931 record on Drugs@FDA; every arginine label on DailyMed.
Highlights of the record
FDA label of April 2, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageR-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.
Forms and strengths
- 10 g/100ml
Injection (solution).
On the market
- Earliest approval on file
- February 28, 1973 R-Gene 10, Pharmacia And Upjohn; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 5 more by firms not listed as its makers
- FAERS reports
- 101 through July 30, 2026
What is arginine used for?
From the label: indications and usageR-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. […]
Source: FDA drug label (R-Gene), Pharmacia & Upjohn Company LLC, effective April 2, 2024 (SPL set 6accf33f-9841-4327-8923-93c42020ef12), via openFDA; the full label on DailyMed
Is there a generic for arginine (R-Gene)?
No generic arginine is approved (Drugs@FDA, October 8, 2026).
- 1973 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has arginine been recalled?
The FDA's Enforcement Report lists 5 recalls naming arginine since 2013: 0 Class I (the most serious), 5 Class II, 0 Class III; 0 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of arginine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical not a listed maker | Lack of Assurance of Sterility |
| November 16, 2017 | Class II | KRS Global Biotechnology, Inc not a listed maker | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. |
| September 21, 2016 | Class II | Wells Pharmacy Network LLC not a listed maker | Lack of Assurance of Sterility |
| May 13, 2016 | Class II | Medaus, Inc. not a listed maker | Lack of Assurance of Sterility |
| July 26, 2013 | Class II | Beacon Hill Medical Pharmacy, P.C. not a listed maker | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the arginine label say about other medicines?
The arginine label names no other medicine on this site. The labels of 6 other medicines name arginine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name arginine
Source: FDA drug label (R-Gene), Pharmacia & Upjohn Company LLC, effective April 2, 2024 (SPL set 6accf33f-9841-4327-8923-93c42020ef12), via openFDA; the full label on DailyMed
What do FAERS reports show for arginine?
The FDA Adverse Event Reporting System holds 101 reports that list arginine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8 are coded as a death and 40 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Arginine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other