Quick answers
- What is L-glutamine used for?
- The FDA-approved label (Endari, Emmaus Medical, Inc., June 20, 2025) says: “Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. ENDARI is an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does L-glutamine have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of L-glutamine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has L-glutamine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes L-glutamine?
- 4 companies list prescription products of L-glutamine in the FDA NDC Directory, including Renova Pharmaceuticals LLC, Emmaus Medical, Inc. and Camber Pharmaceuticals, Inc..
What L-glutamine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. ENDARI is an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older.
— FDA label: Endari, Emmaus Medical, Inc., effective June 20, 2025. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
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.
0 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Powder, for solution |
|---|---|
| Route | Oral |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Endari |
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.
- Renova Pharmaceuticals LLC1 product
- Emmaus Medical, Inc.1 product
- Camber Pharmaceuticals, Inc.1 product
- ANI Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208587 ENDARI | Emmaus Medcl | July 7, 2017 | 4, latest June 18, 2025 2025: Labeling · 2020: Labeling · 2020: Labeling |
Generic approvals (3)
- ANDA215647Novitium Pharma · July 8, 2024
- ANDA219750Pharmobedient · May 14, 2026
- ANDA219722Annora Pharma · May 26, 2026
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
| RxCUI (RxNorm) | 1869684, 1928941 |
|---|---|
| SPL set ID of the quoted label | d5a783f4-12ef-4326-8faa-40018e45ba3b |
| FDA labels (SPL) | 4 |
| FDA applications | NDA208587, 3 ANDA |
| Active ingredients (FDA) | GLUTAMINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Endari, Emmaus Medical, Inc., effective June 20, 2025; 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 →