United States· US:0338-1130_c874a813-b145-4f7f-833e-97d6c4dd727c
Premasol - sulfite-free (Amino Acid)
A medicinal product containing leucine; lysine acetate; isoleucine; valine; histidine; phenylalanine; threonine; methionine; tryptophan; tyrosine; arginine; proline; alanine; glutamic acid; serine; glycine; aspartic acid; taurine; cysteine hydrochloride, registered in United States by Baxter Healthcare Company.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE
- Manufacturer
- Baxter Healthcare Company
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 6
- ndc110338113003500 mL in 1 BAG (0338-1130-03)
- ndc1103381130041000 mL in 1 BAG (0338-1130-04)
- ndc1103381130062000 mL in 1 BAG (0338-1130-06)
- ndc110338-1130-03
- ndc110338-1130-04
- ndc110338-1130-06
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Leucine; lysine acetate; isoleucine; valine; histidine; phenylalanine; threonine; methionine; tryptophan; tyrosine; arginine; proline; alanine; glutamic acid; serine; glycine; aspartic acid; taurine; cysteine hydrochloride in 2 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
Authorised across Europe · EMA
The same active substance is authorised in 15 EEA countries. Names it is sold under:
- Belgium · Vaminolact
- Denmark · Vaminolac
- Estonia · Vaminolact
- Finland · Vaminolac
- Greece · Vamin Infant
- Ireland · Vaminolact
- Iceland · Vaminolac
- Lithuania · Vaminolact
- Luxembourg · Vaminolact
- Latvia · Vaminolact
- Netherlands · Vaminolact
- Norway · Vaminolac
- Portugal · Vaminolact
- Sweden · Vaminolac
- Slovenia · Vaminolact Za Otroke
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/9a3dd133-8c5c-4ce4-ad69-4b086f62465c GET /v1/drugs/9a3dd133-8c5c-4ce4-ad69-4b086f62465c?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": "INTRAVENOUS",
"source": "ndc",
"strength": "1.4; .82; .82; .78; .48; .48; .42; .34; .2; .24; 1.2; .68; .54; .5; .38; .36; .32; 25; .016",
"substance": "LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE",
"productndc": "0338-1130",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL",
"application_number": "ANDA075880",
"marketing_category": "ANDA"
}See everything about leucine; lysine acetate; isoleucine; valine; histidine; phenylalanine; threonine; methionine; tryptophan; tyrosine; arginine; proline; alanine; glutamic acid; serine; glycine; aspartic acid; taurine; cysteine hydrochloride.
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.