Prescription drug · ANDA
Betaine NDC 0713-0352
Betaine 1 g/g · Powder, For solution · Oral · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0352-81 | 00713035281 | 180 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
N400713035281followed by a unit qualifier and the quantityPackage 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.
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.