Betaine Anhydrous For Oral Solution 1 g/g Powder, For Solution, 180 g
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Betaine is used to treat homocystinuria (an inherited condition in which the body cannot break down a certain protein, causing build-up of homocysteine in the blood). Increased amounts of homocysteine in the body can cause symptoms such as extreme tiredness, seizures, dislocation of the lens of the eye, abnormal bone structure, osteoporosis (weak bones), blood clots, or decreased weight or rate of weight gain and slowed development in children. Betaine is in a class of medications called nutrients. It works by decreasing the amount of homocysteine in the blood.
Read the full MedlinePlus article ↗- Homocystinuria is a rare inherited condition where your body can't break down an amino acid called homocysteine properly, so it builds up in your blood to harmful levels. Over time...
- What exactly is homocystinuria, and why do I need this medication for it?
- You measure out your dose using the scoop that comes in the package — don't estimate it by eye. Then you stir it into 4 to 6 ounces of water, juice, milk, or formula until it's com...
- How do I prepare and take the oral powder correctly?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Betaine Anhydrous (prescription drug) — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 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 system | Per mL | Per 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Betaine 1 g/g 00713-0352-81 | Cosette | 180 g | — | AB | FDA listed | — |
| Cystadane 1 g/g 52276-0400-01 | Recordati | 180 g | — | AB | FDA listed | — |
| Betaine Anhydrous 1 g/g 71863-0115-18 | Eton | 180 g | — | AB | FDA listed | — |
| Betaine Anhydrous For Oral Solution 1 g/gthis 55792-0002-01 | Lukare | 180 g | — | AB | Discontinued | — |
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⏳ Availability & generic status
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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 55792-0002-01 You're viewing this | 180 g in 1 BOTTLE (55792-002-01) | 2022-02-11 | Inactivated by FDA |
🧭 About this NDC listing & data coverage
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 | ✓ Available |
| 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. |
Questions about this listing
Why is there no price listed?
What does the discontinued status mean for this NDC?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
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Do I need a prescription for this product?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Betaine Anhydrous for Oral Solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Included within the category of homocystinuria are: • Cystathionine beta-synthase (CBS) deficiency • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency • Cobalamin cofactor metabolism (cbl) defect Betaine Anhydrous for Oral Solution is a methylating agent indicated in pediatric and adult patients for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations.
Included within the category of homocystinuria are ( 1 ): • Cystathionine beta-synthase (CBS) deficiency • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency • Cobalamin cofactor metabolism (cbl) defect
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Adults and Pediatric Patients 3 Years of Age and Older • The recommended dosage is 6 grams per day, administered orally in divided doses of 3 grams twice daily. ( 2.1 ) Pediatric Patients Less than 3 Years of Age • The recommended starting dosage is 100 mg/kg/day, administered orally in divided doses of 50 mg/kg twice daily, and then increased weekly by 50 mg/kg increments. ( 2.1 ) • Monitor patient response by plasma homocysteine concentrations.
( 2.1 ) • Increase the dosage gradually until the plasma total homocysteine concentration is undetectable or present only in small amounts. ( 2.1 ) Preparation and Administration Instructions • Prescribed amount of Betaine Anhydrous for Oral Solution should be measured with the measuring scoop provided and then dissolved in 4 to 6 ounces of water, juice, milk, or formula until completely dissolved, or mixed with food for immediate ingestion. ( 2.2 )
2.1Dosage Therapy with Betaine Anhydrous for Oral Solution should be directed by physicians knowledgeable in the management of patients with homocystinuria. Adults and Pediatric Patients 3 Years of Age and Older The recommended dosage is 6 grams per day, administered orally in divided doses of 3 grams twice daily. Pediatric Patients Less than 3 Years of Age The recommended starting dosage is 100 mg/kg/day divided in twice daily doses, and then increased weekly by 50 mg/kg increments.
Monitoring Monitor patient response to Betaine Anhydrous for Oral Solution by homocysteine plasma concentration. Increase the dosage in all patients gradually until the plasma total homocysteine concentration is undetectable or present only in small amounts. An initial response in homocysteine plasma concentrations usually occurs within several days and steady state plasma concentrations occur within a month.
Monitor plasma methionine concentrations in patients with CBS deficiency [See Warnings and Precautions ( 5.1 )]. Maximum Dosage Dosages of up to 20 grams/day have been necessary to control homocysteine concentrations in some patients. However, one pharmacokinetic and pharmacodynamic in vitro simulation study indicated minimal benefit from exceeding a twice-daily dosing schedule and a 150 mg/kg/day dosage for Betaine Anhydrous for Oral Solution.
2.2Preparation and Administration Instructions • Shake bottle lightly before removing cap. • Measure the number of scoops for the patient's dose with the scoop provided. One level scoop (1.5 mL) is equivalent to 1 gram of betaine anhydrous powder. • Mix powder with 4 to 6 ounces (120 to 180 mL) of water, juice, milk, or formula until completely dissolved, or mix with food, then ingest mixture immediately. • Always replace the cap tightly after using and protect the bottle from moisture.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Betaine Anhydrous for Oral Solution is a white, granular, hygroscopic powder for oral solution available in bottles containing 180 grams of betaine anhydrous. For oral solution: in bottles containing 180 grams of betaine anhydrous. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. • None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hypermethioninemia in Patients with CBS Deficiency: Betaine Anhydrous for Oral Solution may worsen elevated plasma methionine concentrations and cerebral edema has been reported. Monitor plasma methionine concentrations in patients with CBS deficiency. Keep plasma methionine concentrations below 1,000 micromol/L through dietary modification and, if necessary, a reduction of Betaine Anhydrous for Oral Solution dosage. ( 5.1 )
5.1Hypermethioninemia in Patients with CBS Deficiency Patients with homocystinuria due to cystathionine beta-synthase (CBS) deficiency may also have elevated plasma methionine concentrations. Treatment with Betaine Anhydrous for Oral Solution may further increase methionine concentrations due to the remethylation of homocysteine to methionine. Cerebral edema has been reported in patients with hypermethioninemia, including patients treated with Betaine Anhydrous for Oral Solution [ see Adverse Reactions ( 6.2 ) ].
Monitor plasma methionine concentrations in patients with CBS deficiency. Plasma methionine concentrations should be kept below 1,000 micromol/L through dietary modification and, if necessary, a reduction of Betaine Anhydrous for Oral Solution dosage.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: • Hypermethioninemia and cerebral edema in patients with CBS deficiency [ see Warnings and Precautions ( 5.1 ) ]. Most common adverse reactions (> 2%) are: nausea and gastrointestinal distress, based on physician survey. ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Lukare Medical, LLC at 1-855-752-9317, 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 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 assessment of clinical adverse reactions is based on a survey study of 41 physicians, who treated a total of 111 homocystinuria patients with Betaine Anhydrous for Oral Solution. Adverse reactions were retrospectively recalled and were not collected systematically in this open-label, uncontrolled, physician survey.
Thus, this list may not encompass all types of potential adverse reactions, reliably estimate their frequency, or establish a causal relationship to drug exposure. The following adverse reactions were reported ( Table 1 ): Table 1: Number of Patients with Adverse Reactions to Betaine Anhydrous for Oral Solution by Physician Survey Adverse Reactions Number of Patients Nausea 2 Gastrointestinal distress 2 Diarrhea 1 "Bad Taste" 1 "Caused Odor" 1 Questionable psychological changes 1 “Aspirated the powder” 1
6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of Betaine Anhydrous for Oral Solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Severe cerebral edema and hypermethioninemia have been reported within 2 weeks to 6 months of starting Betaine Anhydrous for Oral Solution therapy, with complete recovery after discontinuation of Betaine Anhydrous for Oral Solution.
All patients who developed cerebral edema had homocystinuria due to CBS deficiency and had severe elevation in plasma methionine concentrations (range 1,000 to 3,000 microM). As cerebral edema has also been reported in patients with hypermethioninemia, secondary hypermethioninemia due to betaine therapy has been postulated as a possible mechanism of action [ see Warnings and Precautions ( 5.1 ) ]. Other adverse reactions include: anorexia, agitation, depression, irritability, personality disorder, sleep disturbed, dental disorders, diarrhea, glossitis, nausea, stomach discomfort, vomiting, hair loss, hives, skin odor abnormalities, and urinary incontinence.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from a limited number of published case reports and postmarketing experience with Betaine Anhydrous for Oral Solution use in pregnancy have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with betaine. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 betaine in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Betaine Anhydrous for Oral Solution and any potential adverse effects on the breastfed child from Betaine Anhydrous for Oral Solution or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of Betaine Anhydrous for Oral Solution have been established in pediatric patients. The majority of case studies of homocystinuria patients treated with Betaine Anhydrous for Oral Solution have been pediatric patients, including patients ranging in age from 24 days to 17 years [see Clinical Studies ( 14 )]. Children younger than 3 years of age may benefit from dose titration [see Dosage and Administration ( 2.1 )].
🆘 Overdosage ▾
10 OVERDOSAGE There is no information on Betaine Anhydrous for Oral Solution overdose in humans. In an acute toxicology study in rats, death occurred frequently at doses equal to or greater than 10 g/kg.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Betaine Anhydrous for Oral Solution acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria. Betaine occurs naturally in the body. It is a metabolite of choline and is present in small amounts in foods such as beets, spinach, cereals, and seafood.
12.2Pharmacodynamics Betaine Anhydrous for Oral Solution was observed to lower plasma homocysteine concentration in three types of homocystinuria, including CBS deficiency; MTHFR deficiency; and cbl defect. Patients have taken Betaine Anhydrous for Oral Solution for many years without evidence of tolerance. There has been no demonstrated correlation between Betaine concentration and homocysteine concentration.
In CBS-deficient patients, large increases in methionine concentration over baseline have been observed. Betaine Anhydrous for Oral Solution has also been demonstrated to increase low plasma methionine and S-adenosylmethionine (SAM) concentrations in patients with MTHFR deficiency and cbl defect.
12.3Pharmacokinetics Pharmacokinetic studies of Betaine Anhydrous for Oral Solution are not available. Plasma concentrations following administration of Betaine Anhydrous for Oral Solution have not been measured in patients and have not been correlated to homocysteine concentration.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Betaine Anhydrous for Oral Solution is available in plastic bottles containing 180 grams of betaine anhydrous as a white, granular, hygroscopic powder. Each bottle is equipped with a plastic child-resistant cap and is supplied with a polypropylene measuring scoop. One level scoop (1.5 mL) is equal to 1 gram of betaine anhydrous powder.
NDC 55792-002-01 180 g/bottle Betaine Anhydrous for Oral Solution can be ordered by calling Lukare Medical, LLC., Customer service at 1-855-752-9317. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture.
📋 Description ▾
11 DESCRIPTION Betaine Anhydrous for Oral Solution is an agent for the treatment of homocystinuria. It contains no ingredients other than anhydrous betaine. Betaine Anhydrous for Oral Solution is a white, granular, hygroscopic powder, which is diluted in water and administered orally. The chemical name of betaine anhydrous powder is trimethylglycine. It has a molecular weight of 117.15. The structural formula is: Betaine anhydrous structural formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Preparation and Administration Instructions Instruct patients and caregivers to administer Betaine Anhydrous for Oral Solution as follows: • Shake bottle lightly before removing cap. • Measure the number of scoops for the patient's dose with the scoop provided. One level scoop (1.5 mL) is equivalent to 1 gram of betaine anhydrous powder. • Mix powder with 4 to 6 ounces (120 to 180 mL) of water, juice, milk, or formula until completely dissolved, or mix with food, then ingest mixture immediately. • Always replace the cap tightly after using and protect bottle from moisture.
Manufactured for and Distributed by: Lukare Medical, LLC. Scotch Plains, NJ 07076 Part No.: LUK L 012