NDC codes

FDA NDC Directory
Product NDC (as listed)0713-0352Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00713-0352Add 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 NDC11-digit (billing)PackageCopy
0713-0352-8100713035281180 g in 1 BOTTLE (0713-0352-81)Marketed from Jan 1, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary)
betaine
Active ingredients
Betaine — 1 g/g
Dosage form
Powder, For solution
Route
Oral
Labeler
Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214864
Marketing start
Listing expires
Other FDA classes
Methylating Activity (Mechanism)
Identifiers
Product ID 0713-0352_0863970c-af47-44c7-8418-65f17df50e68SPL ID 0863970c-af47-44c7-8418-65f17df50e68SPL set ID 99b667fa-b00c-465b-bbed-36f317078115RxCUI 562847UNII 3SCV180C9WUPC 0307130352819
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

N400713035281 followed by a unit qualifier and the quantity

Package 00713-0352-81. 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 .

Indications (excerpt from the label)

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 5,10-methylenetetrahydrofolate reducta…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0713-0352

What is NDC 0713-0352?
0713-0352 is the product NDC for Betaine, Betaine 1 g/g powder, for solution, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Betaine.
What is the active ingredient?
Betaine.
Who is the labeler?
Cosette Pharmaceuticals, Inc., NDC labeler code 0713. 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?
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.

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