Drug Database
Back to search

United States· US:73650-316_a43c4966-e649-4105-b439-eea5232c94f2

TZIELD

A teplizumab product containing teplizumab-mzwv, registered in United States by Provention Bio, Inc.. The same ATC class is registered in 13 of our 19 countries.

ATC A10XX01US 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…normalisedTZIELDATCA10XX01REGISTER NO.US:73650-316_a43c4966…PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about teplizumab-mzwvAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Teplizumab is registered in 13 of 19 countries.

Countries holding a registration under ATC A10XX01 (teplizumab), 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
Search teplizumab products by name

Teplizumab · ATC A10XX01

13 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • 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
teplizumab-mzwv
Manufacturer
Provention Bio, Inc.
Country
United States (US)
ATC code
A10XX01
ATC class
Teplizumab
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    7365031601
    1 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-01) / 2 mL in 1 VIAL, SINGLE-DOSE

Regulatory notes

UNII (FDA substance ID)
S4M959U2IJ
TEPLIZUMAB
RxCUI 2621880
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Teplizumab in 13 other countries

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

All teplizumab products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Teizeild
  • Liechtenstein · Teizeild
  • Norway · Teizeild

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/ddc25b13-aea5-4dfd-8e67-0306d64ad212
GET /v1/drugs/ddc25b13-aea5-4dfd-8e67-0306d64ad212?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": "S4M959U2IJ",
    "rxcui": "2621880",
    "inchikey": null,
    "display_name": "TEPLIZUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "e8a39a5f-139c-4510-9777-71cbb00138fa": {
      "match": "brand_token",
      "title": "TZIELD (TEPLIZUMAB-MZWV) INJECTION [PROVENTION BIO, INC.]",
      "spl_version": "6",
      "published_date": "2026-04-23"
    }
  },
  "productid": "73650-316_a43c4966-e649-4105-b439-eea5232c94f2",
  "productndc": "73650-316",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEPLIZUMAB",
  "proprietary_name": "TZIELD",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761183",
  "marketing_category": "BLA",
  "nonproprietary_name": "teplizumab-mzwv",
  "start_marketing_date": "20221117",
  "active_numerator_strength": "1"
}
API referenceMCP serverPlans

See everything about teplizumab.

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.

Try it freeOpen in the console