United States· US:69387-001_9ebcd7d7-1863-47e9-9c0d-2637d7f4f5af

BAFIERTAM

A other immunosuppressants product containing monomethyl fumarate, registered in United States by Banner Life Sciences LLC. The same ATC class is registered in 2 of our 19 countries.

ATC L04AXOrange BookUS 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…normalisedBAFIERTAMATCL04AXREGISTER NO.US:69387-001_9ebcd7d7…PACKS LISTED1CHECKEDSeptember 12, 2026

Where it is registered

Monomethyl fumarate is registered in 2 of 19 countries.

Countries holding a registration under ATC L04AX (other immunosuppressants), each read from that country’s own register.

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

Monomethyl fumarate · ATC L04AX

2 / 19 countries

  • Polandprice
  • 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
monomethyl fumarate
Manufacturer
Banner Life Sciences LLC
Country
United States (US)
ATC code
L04AX
ATC class
Other immunosuppressants
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    6938700101
    120 CAPSULE in 1 BOTTLE (69387-001-01)

Regulatory notes

UNII (FDA substance ID)
45IUB1PX8R
MONOMETHYL FUMARATE
RxCUI 1546433
Orange Book
N210296
DailyMed SPL labels
1 version tracked

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/fa2c9092-f721-495b-a8b0-3d8be576b771
GET /v1/drugs/fa2c9092-f721-495b-a8b0-3d8be576b771?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.

{
  "unii": {
    "unii": "45IUB1PX8R",
    "rxcui": "1546433",
    "inchikey": "NKHAVTQWNUWKEO-NSCUHMNNSA-N",
    "display_name": "MONOMETHYL FUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "a161f9d4-70f1-4097-957a-eafb35d3274f": {
      "match": "brand_token",
      "title": "BAFIERTAM (MONOMETHYL FUMARATE) CAPSULE [BANNER LIFE SCIENCES LLC\n]",
      "spl_version": "10",
      "published_date": "2025-11-17"
    }
  },
  "productid": "69387-001_9ebcd7d7-1863-47e9-9c0d-2637d7f4f5af",
  "productndc": "69387-001",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210296",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "95MG",
        "product_no": "001",
        "approval_date": "Apr 28, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MONOMETHYL FUMARATE",
  "proprietary_name": "BAFIERTAM",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA210296",
  "marketing_category": "NDA",
  "nonproprietary_name": "monomethyl fumarate",
  "start_marketing_date": "20200428",
  "active_numerator_strength": "95"
}

See everything about monomethyl fumarate.

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.