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NDC 71863-0115-18 Betaine Anhydrous 1 g/g Details
Betaine Anhydrous 1 g/g
Betaine Anhydrous is a ORAL POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eton Pharmaceuticals, Inc.. The primary component is BETAINE.
MedlinePlus Drug Summary
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.
Related Packages: 71863-0115-18Last Updated: 05/19/2024
MedLinePlus Full Drug Details: Betaine
Product Information
| NDC | 71863-0115 |
|---|---|
| Product ID | 71863-115_0ccb85a5-4b8c-b30a-e063-6294a90a781b |
| Associated GPIs | |
| GCN Sequence Number | 029257 |
| GCN Sequence Number Description | betaine POWDER 1G/SCOOP ORAL |
| HIC3 | C7D |
| HIC3 Description | METABOLIC DEFICIENCY AGENTS |
| GCN | 66501 |
| HICL Sequence Number | 012233 |
| HICL Sequence Number Description | BETAINE |
| Brand/Generic | Generic |
| Proprietary Name | Betaine Anhydrous |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Betaine Anhydrous |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, FOR SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/g |
| Substance Name | BETAINE |
| Labeler Name | Eton Pharmaceuticals, Inc. |
| Pharmaceutical Class | Methylating Activity [MoA], Methylating Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210508 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71863-0115-18 (71863011518)
| NDC Package Code | 71863-115-18 |
|---|---|
| Billing NDC | 71863011518 |
| Package | 180 g in 1 BOTTLE (71863-115-18) |
| Marketing Start Date | 2023-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |