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L-glutamine 5 g Powder, For Solution, 60 packets — NDC 84897-057-60 (Billing 84897-0057-60)

by Renova Pharmaceuticals LLC · 60 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET

This is a package of 60 packets of L-glutamine 5 g Powder, For Solution from Renova Pharmaceuticals LLC, marketed since May 2026 and currently FDA-listed. It is this product's only package size.

NDC 84897-0057-60
🏷️ FDA NDC (as labeled) 84897-057-60 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84897-057-60
Product NDC 84897-057
11-digit billing NDC 84897005760
RxCUI 1869684
UNII 0RH81L854J
UPC 0384897057010, 0384897057607
Application # ANDA219750
SPL Set ID 3f324755-159b-40ee-a9f4-e6800558acf3
Established class (EPC) Amino Acid
Chemical class Amino Acids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-14
Route ORAL
Dosage form POWDER, FOR SOLUTION
Substance GLUTAMINE
TE code (Orange Book) AA · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1869684
Why two NDCs? The FDA registers this code as 84897-057-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 84897-0057-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Amino Acid class.

Pharmacologic class Amino Acid
Drug family (ATC) Amino acids and derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It's used to reduce acute complications of sickle cell disease in adults and children 5 and older. It's not a cure, but it's meant to help lower flare-up complications.
  • You take it by mouth twice a day, with the amount based on body weight. Mix it right before taking in a cold or room-temperature drink like water or milk, or in a bit of applesauce...
  • The most common ones are constipation, nausea, headache, stomach pain, cough, and pain in the back, chest, or limbs. Many of these also happen with sickle cell disease. Let me or y...
  • No interaction studies have been done, so we don't have specifics. Please keep your medication list up to date with me so I can check everything you take.
📖 Read our full L-glutamine guide →
3
Nutrient depletion considerations

L-glutamine (prescription drug) may be associated with lower levels of 3 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full L-glutamine (prescription drug) nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $17.88 —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84897-0057-60 You're viewing this Main listing 60 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET 2026-05-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
L-glutamine 5 g 31722-0483-60 Camber 60 packets — AA FDA listed —
Endari 5 g 42457-0420-60 Emmaus 60 packets — AA FDA listed —
L-Glutamine 5 g 70954-0417-20 ANI 60 packets — AA FDA listed —
L-glutamine 5 gthis 84897-0057-60 Renova 60 packets — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerRenova Pharmaceuticals LLC
Application holderRENOVA PHARMACEUTICALS LLC
FDA applicationANDA219750 (ANDA)
Labeler code84897
First marketedMay 2026
Product typeHuman Prescription Drug
Portfolio4 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 58 words ▾

1 INDICATIONS AND USAGE L-glutamine oral powder is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. L-glutamine oral powder 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. (1)

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION 5 grams to 15 grams orally, twice daily based on body weight. (2) Each dose of L-glutamine oral powder should be mixed in 8 oz. (240 mL) of cold or room temperature beverage or 4 oz. to 6 oz. of food before ingestion. (2)

2.1Dosage Administer L-glutamine oral powder orally, twice per day at the dose based on body weight according to Table 1. Table 1. Recommended Dosing Weight in kilograms Weight in pounds Per dose in grams Per day in grams Packets per dose Packets per day less than 30 less than 66 5 10 1 2 30 to 65 66 to 143 10 20 2 4 greater than 65 greater than 143 15 30 3 6

2.2Preparation of Product Mix L-glutamine oral powder immediately before ingestion with 8 oz. (240 mL) of cold or room temperature beverage, such as water, milk or apple juice, or 4 oz. to 6 oz. of food such as applesauce or yogurt. Complete dissolution is not required prior to administration.

2.1Dosage Administer L-glutamine oral powder orally, twice per day at the dose based on body weight according to Table 1. Table 1. Recommended Dosing Weight in kilograms Weight in pounds Per dose in grams Per day in grams Packets per dose Packets per day less than 30 less than 66 5 10 1 2 30 to 65 66 to 143 10 20 2 4 greater than 65 greater than 143 15 30 3 6

2.2Preparation of Product Mix L-glutamine oral powder immediately before ingestion with 8 oz. (240 mL) of cold or room temperature beverage, such as water, milk or apple juice, or 4 oz. to 6 oz. of food such as applesauce or yogurt. Complete dissolution is not required prior to administration.

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral powder: 5 grams of L–glutamine as a white crystalline powder in paper-foil-plastic laminate packets. Oral Powder: 5 grams of L-glutamine powder per paper-foil-plastic laminate packet. (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None None (4)

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (incidence > 10%) are constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain. (6) To report SUSPECTED ADVERSE REACTIONS, contact Renova Pharmaceuticals LLC. at 1-888-211-5593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to L-glutamine oral powder in 187 patients, including 136 exposed for 6 months and 109 exposed for ≥1 year. L-glutamine oral powder was studied in 2 placebo-controlled clinical trials (a phase 3 study, n=230 and a phase 2 study, n=70).

In these trials, patients with sickle cell anemia or sickle β 0 -thalassemia were randomized to receive L-glutamine oral powder (n=187) or placebo (n=111) orally twice daily for 48 weeks followed by 3 weeks of tapering. Both studies included pediatric and adult patients (5-58 years of age) and 54% were female. The majority of patients were black (97.3%), had a diagnosis of sickle cell anemia (89.9%) and were receiving hydroxyurea at baseline (63.4%).

Treatment discontinuation due to adverse reactions was reported in 2.7% (n=5) of patients receiving L-glutamine oral powder. These adverse reactions included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash. Serious adverse reactions were reported in both treatment groups, more frequently in the placebo group, and were consistent with the underlying disease.

Three deaths (3/187=1.6%) occurred during the study in the L-glutamine oral powder treatment group as compared to none in the placebo treatment group. None of the deaths were considered to be related to L-glutamine oral powder treatment. Adverse reactions occurring in greater than 10% of patients treated with L-glutamine oral powder are shown in Table 2 below.

Table 2. Adverse Reactions Occurring at an Incidence > 10% in Clinical Studies of L-glutamine oral powder Adverse reaction L-glutamine oral powder N = 187 (%) Placebo N = 111 (%) Constipation 21 18 Nausea 19 14 Headache 18 15 Abdominal Pain Abdominal pain = abdominal pain and abdominal pain, upper 17 16 Cough 16 14 Pain in extremity 13 7 Back pain 12 5 Chest pain 12 8

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on L-glutamine oral powder use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies were not conducted with L-glutamine oral powder. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications.

The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2Lactation Risk Summary There are no data on the presence of L-glutamine oral powder in human milk, the effect on the breastfed infant or the effect on milk production. The developmental and health benefits from breastfeeding should be considered along with the mother’s clinical need for L-glutamine oral powder and any potential adverse effects on the breastfed child from L-glutamine oral powder or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of L-glutamine oral powder have been established in pediatric patients 5 years and older. Use of L-glutamine oral powder is supported by evidence from 2 placebo-controlled studies in adult and pediatric patients with sickle cell disease. The clinical studies enrolled 110 pediatric patients in the following age groups: 46 children (5 years up to less than 12 years) and 64 adolescents (12 years to less than 17 years).

The safety and effectiveness of L-glutamine oral powder in pediatric patients with sickle cell disease younger than 5 years old has not been established.

8.5Geriatric Use Clinical studies of L-glutamine oral powder did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🤰 Pregnancy 98 words ▾

8.1Pregnancy Risk Summary There are no available data on L-glutamine oral powder use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies were not conducted with L-glutamine oral powder. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications.

The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

🧒 Pediatric Use 99 words ▾

8.4Pediatric Use The safety and effectiveness of L-glutamine oral powder have been established in pediatric patients 5 years and older. Use of L-glutamine oral powder is supported by evidence from 2 placebo-controlled studies in adult and pediatric patients with sickle cell disease. The clinical studies enrolled 110 pediatric patients in the following age groups: 46 children (5 years up to less than 12 years) and 64 adolescents (12 years to less than 17 years).

The safety and effectiveness of L-glutamine oral powder in pediatric patients with sickle cell disease younger than 5 years old has not been established.

🧓 Geriatric Use 85 words ▾

8.5Geriatric Use Clinical studies of L-glutamine oral powder did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 44 words ▾

10 OVERDOSAGE Single oral doses of L-glutamine at about 20 g/kg to 22 g/kg, 8 g/kg to 11 g/kg, and 19 g/kg were lethal in mice, rats, and rabbits, respectively. Supportive measures should be undertaken in the event of overdose of L-glutamine oral powder.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of the amino acid L-glutamine in treating sickle cell disease (SCD) is not fully understood. Oxidative stress phenomena are involved in the pathophysiology of SCD. Sickle red blood cells (RBCs) are more susceptible to oxidative damage than normal RBCs, which may contribute to the chronic hemolysis and vaso-occlusive events associated with SCD.

The pyridine nucleotides, NAD + and its reduced form NADH, play roles in regulating and preventing oxidative damage in RBCs. L-glutamine may improve the NAD redox potential in sickle RBCs through increasing the availability of reduced glutathione.

12.2Pharmacodynamics In vivo analyses demonstrated that L-glutamine supplementation improved NAD redox potential.

12.3Pharmacokinetics The pharmacokinetics of L-glutamine has been studied in healthy subjects and a variety of disease states. Relevant results from published literature are summarized below. Absorption Following single-dose oral administration of L-glutamine at 0.1 g/kg, mean peak L-glutamine concentration was 1028 μM (or 150 mcg/mL) occurring approximately 30 minutes after administration.

The pharmacokinetics following multiple oral doses at 0.1 g/kg, 0.3 g/kg, and 0.6 g/kg found peak concentrations increasing with each dose, but maximum concentration did not increase proportionally to the dose, suggesting a saturable absorption process. The peak concentration was seen occurring approximately one hour after administration. There was no accumulation of L-glutamine levels upon multiple oral doses administered twice-daily.

Effect of Food No significant change in L-glutamine concentration was associated with food, suggesting that L-glutamine can be taken with or without food. Distribution After multiple oral doses, the apparent volume of distribution was estimated to be approximately 750 mL/kg. Elimination After an intravenous bolus dose, the terminal elimination half-life of L-glutamine was approximately one hour.

Metabolism Endogenous L-glutamine participates in various metabolic activities, including the formation of glutamate, and synthesis of proteins, nucleotides, and amino sugars. Exogenous L-glutamine is anticipated to undergo similar metabolism. Excretion Metabolism is the major route of disappearance for L-glutamine from the plasma.

Urinary excretion of L-glutamine was less than 0.3% of the administered dose in intravenous infusion studies. Specific Populations In a population pharmacokinetic analysis, body weight was found to be a significant covariate of L-glutamine exposures supporting the tiered body weight based dosing of L-glutamine oral powder. The pharmacokinetics of L-glutamine oral powder has not been studied in subjects with renal or hepatic impairment.

Drug Interactions No drug interaction studies have been conducted.

🧬 Mechanism of Action 97 words ▾

12.1Mechanism of Action The mechanism of action of the amino acid L-glutamine in treating sickle cell disease (SCD) is not fully understood. Oxidative stress phenomena are involved in the pathophysiology of SCD. Sickle red blood cells (RBCs) are more susceptible to oxidative damage than normal RBCs, which may contribute to the chronic hemolysis and vaso-occlusive events associated with SCD.

The pyridine nucleotides, NAD + and its reduced form NADH, play roles in regulating and preventing oxidative damage in RBCs. L-glutamine may improve the NAD redox potential in sickle RBCs through increasing the availability of reduced glutathione.

📦 How Supplied / Storage and Handling 40 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING L-glutamine oral powder is supplied in paper-foil-plastic laminate packets containing 5 grams of L-glutamine white crystalline powder. Carton of 60 Packets: NDC 90058-057-60 Store at 20°C to 25°C (68°F to 77°F) away from direct sunlight.

📋 Description 72 words ▾

11 DESCRIPTION L-glutamine oral powder (L-glutamine) is an amino acid. L-glutamine is designated chemically as (S)-2-aminoglutaramic acid, L-glutamic acid 5-amide, or (S)-2,5-diamino-5-oxopentanoic acid. The molecular formula is C 5 H 10 N 2 O 3 with the molecular weight of 146.15 g/mol and the following structural formula: L-glutamine oral powder is formulated as a white crystalline powder and is packaged as 5 grams in a paper-foil-plastic laminate packet for oral administration. chemstructure

💬 Information for Patients 88 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Dosage and Administration Advise patient to take a missed dose as soon as they remember. Patient should not double the dose that they take.

Instruct patient to mix each dose in 8 oz. (240 mL) of cold or room temperature beverage or 4 to 6 oz. of food. Advise patient that complete dissolution is not required prior to administration.

Distributed by: Renova Pharma LLC 161 Dwight Pl, Fairfield, NJ 07004 Rev. 05/2026

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics The pharmacokinetics of L-glutamine has been studied in healthy subjects and a variety of disease states. Relevant results from published literature are summarized below. Absorption Following single-dose oral administration of L-glutamine at 0.1 g/kg, mean peak L-glutamine concentration was 1028 μM (or 150 mcg/mL) occurring approximately 30 minutes after administration.

The pharmacokinetics following multiple oral doses at 0.1 g/kg, 0.3 g/kg, and 0.6 g/kg found peak concentrations increasing with each dose, but maximum concentration did not increase proportionally to the dose, suggesting a saturable absorption process. The peak concentration was seen occurring approximately one hour after administration. There was no accumulation of L-glutamine levels upon multiple oral doses administered twice-daily.

Effect of Food No significant change in L-glutamine concentration was associated with food, suggesting that L-glutamine can be taken with or without food. Distribution After multiple oral doses, the apparent volume of distribution was estimated to be approximately 750 mL/kg. Elimination After an intravenous bolus dose, the terminal elimination half-life of L-glutamine was approximately one hour.

Metabolism Endogenous L-glutamine participates in various metabolic activities, including the formation of glutamate, and synthesis of proteins, nucleotides, and amino sugars. Exogenous L-glutamine is anticipated to undergo similar metabolism. Excretion Metabolism is the major route of disappearance for L-glutamine from the plasma.

Urinary excretion of L-glutamine was less than 0.3% of the administered dose in intravenous infusion studies. Specific Populations In a population pharmacokinetic analysis, body weight was found to be a significant covariate of L-glutamine exposures supporting the tiered body weight based dosing of L-glutamine oral powder. The pharmacokinetics of L-glutamine oral powder has not been studied in subjects with renal or hepatic impairment.

Drug Interactions No drug interaction studies have been conducted.

🧬 Pharmacodynamics 13 words ▾

12.2Pharmacodynamics In vivo analyses demonstrated that L-glutamine supplementation improved NAD redox potential.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy of L-glutamine oral powder in sickle cell disease was evaluated in a randomized, double-blind, placebo-controlled, multi-center clinical trial entitled "A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle β 0 -thalassemia" [ NCT01179217 ] (see Table 3). The clinical trial evaluated the efficacy and safety of L-glutamine oral powder in 230 patients (5 to 58 years of age) with sickle cell anemia or sickle β 0 -thalassemia who had 2 or more painful crises within 12 months prior to enrollment.

Eligible patients stabilized on hydroxyurea for at least 3 months continued their therapy throughout the study. The trial excluded patients who had received blood products within 3 weeks, had renal insufficiency or uncontrolled liver disease, or were pregnant (or planning pregnancy) or lactating. Study patients received L-glutamine oral powder or placebo for a treatment duration of 48 weeks followed by 3 weeks of tapering.

Efficacy was demonstrated by a reduction in the number of sickle cell crises through Week 48 and prior to the start of tapering among patients that received L-glutamine oral powder compared to patients who received placebo. This clinical benefit was observed irrespective of hydroxyurea use. A sickle cell crisis was defined as a visit to an emergency room/medical facility for sickle cell disease-related pain which was treated with a parenterally administered narcotic or parenterally administered ketorolac.

In addition, the occurrence of chest syndrome, priapism, and splenic sequestration were considered sickle cell crises. Treatment with L-glutamine oral powder also resulted in fewer hospitalizations due to sickle cell pain at Week 48, fewer cumulative days in hospital and a lower incidence of acute chest syndrome. Table 3.

Results from the L-glutamine oral powder Clinical Trial in Sickle Cell Disease Event L-glutamine oral powder (n = 152) Placebo (n = 78) Median number of sickle cell crises (min, max) Measured through 48 weeks of treatment 3 (0, 15) 4 (0, 15) Median number of hospitalizations for sickle cell pain (min, max) 2 (0, 14) 3 (0, 13) Median cumulative days hospitalized (min, max) 6.5 (0, 94) 11 (0, 187) Median time (days) to first sickle cell crisis (95% CI) , Hazard Ratio=0.69 (95% CI=0.52, 0.93), estimated based on unstratified Cox’s proportional model.

Median time and 95% CI were estimated based on the Kaplan Meier method. 84 (62,109) 54 (31, 73) Patients with occurrences of acute chest syndrome (%) 13 (8.6%) 18 (23.1%) The recurrent crisis event time analysis (Figure 1) yielded an intensity rate ratio (IRR) value of 0.75 with 95% CI= (0.62, 0.90) and (0.55, 1.01) based on unstratified models using the Andersen-Gill and Lin, Wei, Yang and Ying methods, respectively in favor of L-glutamine oral powder, suggesting that over the entire 48-week period, the average cumulative crisis count was reduced by 25% from the L-glutamine oral powder group over the placebo group.

Figure 1. Recurrent Event Time for Sickle Cell Crises by Treatment Group *Andersen-Gill: 95% CI (0.62, 0.90); Lin-Wei-Yang-Ying: 95% CI (0.55, 1.01) figure1

🧪 Nonclinical Toxicology 88 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of L-glutamine. L-glutamine was not mutagenic in a bacterial mutagenicity (Ames) assay, nor clastogenic in a chromosome aberration assay in mammalian (Chinese Hamster Lung CHL/IU) cells. Animal reproduction studies and its potential for impairment of fertility have not been conducted with L-glutamine.

It is also not known whether L-glutamine can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 85 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of L-glutamine. L-glutamine was not mutagenic in a bacterial mutagenicity (Ames) assay, nor clastogenic in a chromosome aberration assay in mammalian (Chinese Hamster Lung CHL/IU) cells. Animal reproduction studies and its potential for impairment of fertility have not been conducted with L-glutamine.

It is also not known whether L-glutamine can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.

📄 Patient Package Insert ~2 min read ▾

INSTRUCTIONS FOR USE L-glutamine oral powder Read this Instructions for Use before you start taking L-glutamine oral powder and each time you get a refill. There may be new information. This Instructions for Use does not take the place of talking to your healthcare provider about your medical condition or treatment.

You and your healthcare provider should talk about L-glutamine oral powder before you start taking it and at regular checkups. L-glutamine oral powder is usually taken 2 times a day. Take L-glutamine oral powder as prescribed by your healthcare provider.

You will need the following supplies to mix and take L-glutamine oral powder: Your prescribed dose of L-glutamine oral powder (1, 2, or 3 packets as directed by your healthcare provider). a clean cup or small bowl a spoon You can mix L-glutamine oral powder: with a liquid, such as water, milk, or apple juice Or with food, such as applesauce or yogurt How to mix and take a dose of L-glutamine oral powder. Mixing with Liquid Mixing with Food Step 1: Fill a cup with 8 ounces (240 mL) of liquid or a small bowl with 4 to 6 ounces of food.

The food or liquid should be cold or room temperature. Do not use a hot food or liquid. Step 2: Find the perforations at the top of each side of the L-glutamine oral powder packet.

Use the perforations to fully tear open each L-glutamine oral powder packet. Step 3: Pour the contents of the L-glutamine oral powder packet into the cup or bowl. If more than 1 packet is needed, repeat steps 2 and 3 above for all of the packets needed to prepare your prescribed dose of L-glutamine oral powder.

Step 4: Use the spoon to mix the prescribed dose of L-glutamine oral powder with the liquid or food. L-glutamine oral powder may not fully dissolve. You can take your dose of L-glutamine oral powder even if it does not fully dissolve.

Step 5: Drink or eat the prescribed dose of L-glutamine oral powder right away after mixing it. Do not store the L-glutamine oral powder mixture for later use. If you miss a dose of L-glutamine oral powder, take the missed dose as soon as you remember.

Do not double the dose to make up for a missed dose . How should I store L-glutamine oral powder? Store L-glutamine oral powder at room temperature between 68°F to 77°F (20°C to 25°C).

Keep L-glutamine oral powder away from direct sunlight. Keep L-glutamine oral powder and all medicines out of the reach of children. Distributed by: Renova Pharma LLC 161 Dwight Pl, Fairfield, NJ 07004 Rev.

05/2026 1 figure-3 figure-4 figure-5 figure-6 figure-7 figure-8 figure-9 figure-10 figure-11 figure-12

📄 Package Label / Principal Display Panel 22 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Packet Label for L-glutamine Oral Powder, 5 g/Packet Carton Label for L-glutamine Oral Powder, 60 packets/carton label carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for L-Glutamine — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name L-Glutamine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.06M
Claims incl. refills
455
Beneficiaries
255
Spend / beneficiary
$4,175.50
Spend / claim
$2,340.11
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Renova Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Renova Pharmaceuticals LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 84897-0052-01 · Renova 84897-0058-01 · Renova →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.