What is NDC 71863-115?

71863-115 is the product NDC for Betaine Anhydrous, Betaine 1 g/g powder, for solution, listed with the FDA by Eton Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Eton Pharmaceuticals, Inc., NDC labeler code 71863. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Betaine Anhydrous?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Betaine Anhydrous NDC 71863-115 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71863-115Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71863-0115Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71863-115-18	7186301151871863011518	180 g in 1 BOTTLE (71863-115-18)Marketed from Jan 28, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Betaine Anhydrous
Generic name (nonproprietary): betaine anhydrous
Active ingredients: Betaine — 1 g/g
Dosage form: Powder, For solution
Route: Oral
Labeler: Eton Pharmaceuticals, Inc.NDC labeler code 71863
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210508
Marketing start: Jan 28, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Methylating Activity (Mechanism)
Identifiers: Product ID 71863-115_42c7a42b-6a75-69d3-e063-6294a90acc18SPL ID 42c7a42b-6a75-69d3-e063-6294a90acc18SPL set ID ee8a95c3-df9f-6e55-e053-2a95a90ab17bRxCUI 562847UNII 3SCV180C9W
Pharmacologic class: Methylating Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N471863011518 followed by a unit qualifier and the quantity

Package 71863-0115-18. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Feb 2, 2023.

Indications (excerpt from the label)

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: • Cystathionine beta-synthase (CBS) deficiency • 5,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71863-115

What is NDC 71863-115?: 71863-115 is the product NDC for Betaine Anhydrous, Betaine 1 g/g powder, for solution, listed with the FDA by Eton Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Betaine Anhydrous.
What is the active ingredient?: Betaine.
Who is the labeler?: Eton Pharmaceuticals, Inc., NDC labeler code 71863. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Betaine Anhydrous?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.