UNII 0P6C6ZOP5U

ROFLUMILAST

UNII Information

Unique Ingredient Identifier: 0P6C6ZOP5U
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.
Formula: 7598
Molecular Formula, total atoms represented as a molecular structure in a UNII description.
Preferred Substance Name: ROFLUMILAST
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.
InChIKey: OO-57
The InChIKey to a unique identifier for a specific substance or ingredient that is based on its molecular structure. InChIKey stands for International Chemical Identifier Key and is a fixed-length string created from the IUPAC International Chemical Identifier (InChI). The InChIKey is useful in drug development and chemical analysis, where the molecular structure of a substance is an important factor in determining its properties and effects.
SMILES: C17H14Cl2F2N2O3
The Simplified Molecular Input Line Entry System or SMILES is a format used to represent and describe the molecular structure of a substance or ingredient. SMILES uses a series of alphanumeric characters to represent the atoms and bonds in a molecule in conjunction with other symbols and operators to indicate the arrangement and connectivity of the atoms.
Registry Number: 162401-32-3
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: C76890
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: 1091836 (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.
PubChem Compound ID: 449193
The PubChem Compound ID is a unique identifier for a specific substance or ingredient in the PubChem database which is the largest collection of freely accessible chemical information by the National Center for Biotechnology Information. The PubChem database is a resource for drug discovery, development, chemical research, and other applications.
ITIS TSN: DTXSID8044123
The Taxonomic Serial Number is a unique identifier for a specific species of organism in the Integrated Taxonomic Information System. The ITIS is a comprehensive database of taxonomic information on plants, animals, fungi, and microbes, maintained by a partnership of several US government agencies.
Ingredient Type: MNDBXUUTURYVHR-UHFFFAOYSA-N
Substance Type: INGREDIENT SUBSTANCE
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.

  • 3-(CYCLOPROPYLMETHOXY)-N-(3,5-DICHLORO-4-PYRIDINYL)-4-(DIFLUOROMETHOXY)BENZAMIDE - Systematic Name (chemical and taxonomic names)
  • ARQ-151 - Code
  • ARQ-154 (ROFLUMILAST FOAM) - Code
  • B9302-107 - Code
  • B-9302-107 - Code
  • BENZAMIDE, 3-(CYCLOPROPYLMETHOXY)-N-(3,5-DICHLORO-4-PYRIDINYL)-4-(DIFLUOROMETHOXY)- - Systematic Name (chemical and taxonomic names)
  • BY217 - Code
  • BY-217 - Code
  • BYK20869 - Code
  • BYK-20869 - Code
  • DALIRESP - Brand/Trade Name
  • DAXAS - Brand/Trade Name
  • ROFLUMILAST - Name identified as having official status
  • ROFLUMILAST [EMA EPAR] - Common Name
  • ROFLUMILAST [INN] - Common Name
  • ROFLUMILAST [JAN] - Common Name
  • ROFLUMILAST [MART.] - Common Name
  • ROFLUMILAST [MI] - Common Name
  • ROFLUMILAST [ORANGE BOOK] - Common Name
  • ROFLUMILAST [USAN] - Common Name
  • ROFLUMILAST [VANDF] - Common Name
  • ROFLUMILAST [WHO-DD] - Common Name
  • ZORYVE - Brand/Trade Name

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.
PubChem
The PubChem database by the National Library of Medicine includes the chemical structures of small organic molecules and information on their biological 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
0310-0088Proprietary Name: Daliresp RoflumilastTabletOralAstrazeneca Pharmaceuticals LpACTIVE
0310-0095Proprietary Name: Daliresp RoflumilastTabletOralAstrazeneca Pharmaceuticals LpACTIVE
0378-1905Proprietary Name: Roflumilast RoflumilastTabletOralMylan Pharmaceuticals Inc.ACTIVE
0904-7399Proprietary Name: Roflumilast RoflumilastTabletOralMajor PharmaceuticalsACTIVE
31722-623Proprietary Name: Roflumilast RoflumilastTabletOralCamber Pharmaceuticals, Inc.ACTIVE
42571-259Proprietary Name: Roflumilast RoflumilastTabletOralMicro Labs LimitedACTIVE
43547-005Proprietary Name: Roflumilast RoflumilastTabletOralSolco Healthcare Us, Llc.ACTIVE
59651-275Proprietary Name: Roflumilast RoflumilastTabletOralAurobindo Pharma LimitedACTIVE
60687-786Proprietary Name: Roflumilast RoflumilastTabletOralAmerican Health PackagingACTIVE
64380-786Proprietary Name: Roflumilast RoflumilastTabletOralStrides Pharma Science LimitedACTIVE
68382-969Proprietary Name: Roflumilast RoflumilastTabletOralZydus Pharmaceuticals Usa Inc.ACTIVE
70771-1674Proprietary Name: Roflumilast RoflumilastTabletOralZydus Lifesciences LimitedACTIVE
72205-200Proprietary Name: Roflumilast RoflumilastTabletOralNovadoz Pharmaceuticals LlcACTIVE
72205-201Proprietary Name: Roflumilast RoflumilastTabletOralNovadoz Pharmaceuticals LlcACTIVE
80610-130Proprietary Name: Zoryve RoflumilastCreamTopicalArcutis Biotherapeutics, Inc.ACTIVE
80610-430Proprietary Name: Zoryve RoflumilastAerosol, FoamTopicalArcutis Biotherapeutics, Inc.ACTIVE