UNII 2P471X1Z11

OMALIZUMAB

UNII Information

Unique Ingredient Identifier: 2P471X1Z11
The Unique Ingredient Identifier (UNII) is a unique alphanumeric code assigned to a specific substance or ingredient by the FDA (Food and Drug Administration). UNII codes are non-proprietary, free, unique, unambiguous and nonsemantic. Each UNII code consists of 10 characters with both letters and numbers. The first two characters represent the source of the substance while the remaining eight characters represent the specific substance. UNII codes are primarily used to identify and track substances in several drug databases and regulatory documents related to drugs, biologics, and medical devices.
Preferred Substance Name: OMALIZUMAB
The Preferred Substance Name (PSN) is the official or preferred name of a substance or ingredient. The preferred name provides a standardized and consistent name for each substance is used in the UNII code system. The preferred name may differ from other names also commonly used to refer the same substance. The PSN is usually the name used by regulatory agencies like the FDA.
Registry Number: 242138-07-4
The Registry Number is the unique numerical identifiers assigned to a substance or ingredient by the Chemical Abstracts Service (CAS). The CAS registry number is a used and recognized standard identifier by many industries and regulatory agencies. The Registry Number facilitates cross-referencing substances between different databases that may use different naming conventions or identifiers.
NCI Thesaurus Concept Code: C29299
The NCI Thesaurus give reference terminology for many systems. The code includes vocabulary for clinical care, translational research, basic research, public information and administrative activities.
UNII to RxNorm Crosswalk: 302379 (RXCUI)
The RxNorm Ingredient Concept Code is the numeric code assigned to a specific substance or ingredient by the National Library of Medicine's RxNorm system. By including the RxNorm code in the UNII code system it is possible to crossover UNII codes to RxNom.
INN ID: 8039
Sequential number assigned by World Health Organization's International Nonproprietary Name (INN).
Ingredient Type: INGREDIENT SUBSTANCE
Substance Type: 4fb370f9-8e68-4071-9638-b7227c5f79c6
The International Organization for Standardization - ISO 11238 substance type is used as a data element in the UNII code system to provide additional information about the type of substance being identified.

UNII Synonyms and Mappings

The following synonyms and mappings provide alternative ways to refer to the same substance or ingredient. Synonyms may include different names or spellings, alternate chemical names, trade names, or other common names.

  • IGE25 - Code
  • IMMUNOGLOBULIN G (HUMAN-MOUSE MONOCLONAL E25 CLONE PSV1E26 -CHAIN ANTIHUMAN IMMUNOGLOBULIN E FC REGION), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL E25 CLONE PSVIE126 -CHAIN, DIMER - Common Name
  • IMMUNOGLOBULIN G, ANTI-(HUMAN IMMUNOGLOBULIN E FC REGION) (HUMAN-MOUSE MONOCLONAL E25 CLONE PSVIE26 -CHAIN), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL E25 CLONE PSVIE26 -CHAIN, DIMER - Common Name
  • OMALIZUMAB (GENETICAL RECOMBINATION) - Name identified as having official status
  • OMALIZUMAB [EMA EPAR] - Common Name
  • OMALIZUMAB [JAN] - Common Name
  • OMALIZUMAB [MART.] - Common Name
  • OMALIZUMAB [MI] - Common Name
  • OMALIZUMAB [PURPLE BOOK CDER] - Common Name
  • OMALIZUMAB [USAN] - Common Name
  • OMALIZUMAB [VANDF] - Common Name
  • OMALIZUMAB - Name identified as having official status
  • OMALIZUMAB [WHO-DD] - Common Name
  • RG-3648 - Code
  • RHUMAB-E25 - Code
  • XOLAIR - Brand/Trade Name
  • OMALIZUMAB [INN] - Common Name
  • CT-P39 - Code
  • CTP-39 - Code
  • CTP39 - Code
  • OMALIZUMAB BIOSIMILAR (CT-P39) - Common Name
  • OMLYCLO - Brand/Trade Name
  • OMALIZUMAB-IGEC - Name identified as having official status
  • GBR 310 - Code
  • GBR-310 - Common Name
  • OMALIZUMAB BIOSIMILAR - GLENMARK PHARMACEUTICALS - Common Name
  • OMALIZUMAB BIOSIMILAR - SYNERMORE - Common Name
  • SYN-008 - Code
  • SYN008 - Code

UNII Resources

Common Chemistry
CAS Common Chemistry is an open community resource of the American Chemical Society for accessing chemical information. The chemical information in the CAS database is curated by expert scientists and includes information of common and frequently regulated chemicals and information applicable to high school and undergraduate chemistry classes.
Inxight Drugs
The National Center for Advancing Translational Sciences (NCATS) Inxight Drugs database has a comprehensive drug development information. The NCATS Inxight Drugs includes manually curated data provided by private companies and FDA. The database has marketing and regulatory status information, rigorous drug ingredient definitions, biological activity, clinical use, etc.
DailyMed Regulated Products
The National Library of Medicine DailyMed is a searchable database that includes the most recent product labeling information submitted to the FDA by private companies.
NCATS GSRS Full Record
The Global Substance Registration System (GSRS) was designed to facilitate global monitoring of human and animal medicinal, food, tobacco, and cosmetic products. GSRS includes unique substance identifiers consistent with the ISO 11238 standard.
NCI Thesaurus
NCI Thesaurus (NCIt) by the National Cancer Institute provides reference terminology for clinical care, translational and basic research, and public information and administrative activities.

UNII Crossover to NDC Codes

This unique ingredient identifier is listed as an ingredient or substance in the following products in the NDC directory:

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Status
50242-040Proprietary Name: Xolair OmalizumabInjection, SolutionSubcutaneousGenentech, Inc.ACTIVE
50242-214Proprietary Name: Xolair Pfs OmalizumabInjection, SolutionSubcutaneousGenentech, Inc.ACTIVE
50242-215Proprietary Name: Xolair Pfs OmalizumabInjection, SolutionSubcutaneousGenentech, Inc.ACTIVE