United States· US:63545-631_de9c9f85-221b-18d2-e053-2a95a90a3c69
Biotitum
A biotin product containing biotin, registered in United States by Hahnemann Laboratories, INC.. The same ATC class is registered in 9 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Biotin is registered in 9 of 19 countries.
Countries holding a registration under ATC A11HA05 (biotin), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 6 of them publish a price we can compare per daily dose
Biotin · ATC A11HA05
9 / 19 countries
- Czechiaprice
- Franceprice
- Germany
- Japan
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- BIOTIN
- Manufacturer
- Hahnemann Laboratories, INC.
- Country
- United States (US)
- ATC code
- A11HA05
- ATC class
- Biotin
- Defined daily dose
- 5 mg, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 6
- ndc1163545-631-01
- ndc1163545-631-02
- ndc1163545-631-03
- ndc116354563101200 PELLET in 1 VIAL, GLASS (63545-631-01)
- ndc1163545631021200 PELLET in 1 BOTTLE, GLASS (63545-631-02)
- ndc1163545631034000 PELLET in 1 BOTTLE, GLASS (63545-631-03)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Biotin in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomAactiBio 10mg tabletsTriOn Pharma Ltd
- GermanyBeotebalFarmaprojects S.A.U.
- PolandBelbitalNatur Produkt Zdrovit Sp. z o.o.
- CzechiaBEOTEBALZaklady Farmaceutyczne Polpharma SA, Starogard Gdański
- SwitzerlandBiotin Merz 5 mg, TablettenMerz Pharma (Schweiz) AG
- NorwayBio-H-Tin Vitamin HBio-H-Tin Pharma
- Japanビオチン東洋製薬化成
- SpainBEOTEBAL 10 MG COMPRIMIDOSFarmaprojects S.A.U.
Authorised across Europe · EMA
The same active substance is authorised in 14 EEA countries. Names it is sold under:
- Austria · Biogelat, Curatin
- Bulgaria · Белбитал, Беотебал
- Czechia · Beotebal
- Germany · Beotebal, Biotin 10 Mg
- Estonia · Beotebal
- Spain · Medebiotín Fuerte
- France · Bijotebal, Biotine Bayer
- Hungary · Beotebal
- Italy · Biodermatin, Diathynil
- Lithuania · Beicap, Beotebal
- Latvia · Beotebal
- Poland · Belbital, Biotebal
- Romania · Belbital
- Slovakia · Belbital, Beotebal
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/aad6e38c-9d1f-49ef-929f-5e91399b21d4 GET /v1/drugs/aad6e38c-9d1f-49ef-929f-5e91399b21d4?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": "12",
"substance": "BIOTIN",
"productndc": "63545-631",
"dosage_form": "PELLET",
"dea_schedule": null,
"strength_unit": "[hp_C]/1",
"application_number": null,
"marketing_category": "UNAPPROVED HOMEOPATHIC"
}See everything about biotin.
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.