What is NDC 52276-400?

52276-400 is the product NDC for Cystadane (betaine), Betaine 1 g/g powder, for solution, listed with the FDA by Recordati Rare Diseases. It has 1 package NDC, shown above in 10- and 11-digit form.

Recordati Rare Diseases, NDC labeler code 52276. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cystadane?

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.

Cystadane NDC 52276-400 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)52276-400Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52276-0400Add 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
52276-400-01	52276040001	180 g in 1 BOTTLE (52276-400-01)Marketed from Apr 13, 2017

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): Cystadane
Generic name (nonproprietary): betaine
Active ingredients: Betaine — 1 g/g
Dosage form: Powder, For solution
Route: Oral
Labeler: Recordati Rare DiseasesNDC labeler code 52276
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020576
Marketing start: Oct 25, 1996
Listing expires: Dec 31, 2027
Other FDA classes: Methylating Activity (Mechanism)
Identifiers: Product ID 52276-400_3a4fdd66-b72b-4aa3-94bb-bac8af98b150SPL ID 3a4fdd66-b72b-4aa3-94bb-bac8af98b150SPL set ID 31a684d0-cd98-4e46-b43a-ccbd17c41559RxCUI 404539, 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

N452276040001 followed by a unit qualifier and the quantity

Package 52276-0400-01. 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 Apr 24, 2026.

Indications (excerpt from the label)

CYSTADANE ® 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 CYSTADANE 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 me…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 52276-400

What is NDC 52276-400?: 52276-400 is the product NDC for Cystadane (betaine), Betaine 1 g/g powder, for solution, listed with the FDA by Recordati Rare Diseases. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cystadane (Betaine).
What is the active ingredient?: Betaine.
Who is the labeler?: Recordati Rare Diseases, NDC labeler code 52276. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cystadane?: 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.

Cystadane (Betaine) NDC 52276-400