United States· US:0713-0352_0863970c-af47-44c7-8418-65f17df50e68

Betaine

A betaine product containing betaine, registered in United States by Cosette Pharmaceuticals, Inc.. The same ATC class is registered in 15 of our 19 countries.

ATC A16AA06US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedBetaineATCA16AA06REGISTER NO.US:0713-0352_0863970c…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Betaine is registered in 15 of 19 countries.

Countries holding a registration under ATC A16AA06 (betaine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 9 of them publish a price we can compare per daily dose

Betaine · ATC A16AA06

15 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
BETAINE
Manufacturer
Cosette Pharmaceuticals, Inc.
Country
United States (US)
ATC code
A16AA06
ATC class
Betaine
Defined daily dose
6 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    0713035281
    180 g in 1 BOTTLE (0713-0352-81)
  • ndc11
    0713-0352-81

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Betaine in 14 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All betaine products

Authorised across Europe · EMA

The same active substance is authorised in 5 EEA countries. Names it is sold under:

  • France · Citrate De Betaïne Citron Sans Sucre, Édulcoré À La Saccharine Sodique Upsa, Citrate De Betaine Cristers
  • Greece · Alkacitrat
  • Iceland · Amversio, Cystadane
  • Liechtenstein · Amversio, Cystadane
  • Norway · Amversio, Cystadane

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/5f0b0c8a-594f-4641-8d80-0e7dbacce021
GET /v1/drugs/5f0b0c8a-594f-4641-8d80-0e7dbacce021?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "ORAL",
  "source": "ndc",
  "strength": "1",
  "substance": "BETAINE",
  "productndc": "0713-0352",
  "dosage_form": "POWDER, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "g/g",
  "application_number": "ANDA214864",
  "marketing_category": "ANDA"
}

See everything about betaine.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.