tazarotene Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
arotinoid derivatives 2571 118292-40-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tazarotene
  • tazorac
  • fabior
  • AGN-190168
a topical acetylenic retinoid; a topical kerytolytic
  • Molecular weight: 351.46
  • Formula: C21H21NO2S
  • CLOGP: 6.07
  • LIPINSKI: 1
  • HAC: 3
  • HDO: 0
  • TPSA: 39.19
  • ALOGS: -5.67
  • ROTB: 5

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 3.55 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 37.20 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 6.22 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 13, 1997 FDA ALLERGAN

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

SourceCodeDescription
ATC D05AX05 DERMATOLOGICALS
ANTIPSORIATICS
ANTIPSORIATICS FOR TOPICAL USE
Other antipsoriatics for topical use
ATC D05AX55 DERMATOLOGICALS
ANTIPSORIATICS
ANTIPSORIATICS FOR TOPICAL USE
Other antipsoriatics for topical use
FDA CS M0018962 Retinoids
FDA EPC N0000175607 Retinoid
MeSH PA D003879 Dermatologic Agents
MeSH PA D007641 Keratolytic Agents
MeSH PA D009676 Noxae
MeSH PA D013723 Teratogens
CHEBI has role CHEBI:50176 desquamating agent
CHEBI has role CHEBI:50266 prodrugs
CHEBI has role CHEBI:50905 teratogen

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Psoriasis indication 9014002 DOID:8893
Acne vulgaris indication 88616000
Facial Hyperpigmentation indication
Benign Facial Lentigine indication
Facial Fine Wrinkling indication
Facial Hypopigmentation indication
Sunburn contraindication 23346002
Photosensitivity contraindication 90128006
Pregnancy, function contraindication 289908002

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.17 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.01%;0.045% DUOBRII BAUSCH N209354 April 25, 2019 RX LOTION TOPICAL April 25, 2022 NEW PRODUCT
0.045% ARAZLO BAUSCH N211882 Dec. 18, 2019 RX LOTION TOPICAL Dec. 18, 2022 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Retinoic acid receptor beta Nuclear hormone receptor AGONIST EC50 9.10 CHEMBL CHEMBL
Retinoic acid receptor alpha Nuclear hormone receptor AGONIST EC50 7.20 CHEMBL CHEMBL
Retinoic acid receptor gamma Nuclear hormone receptor AGONIST EC50 7.40 CHEMBL CHEMBL

External reference:

IDSource
4021045 VUID
N0000148509 NUI
D01132 KEGG_DRUG
4021045 VANDF
C0253908 UMLSCUI
CHEBI:32184 CHEBI
CHEMBL1657 ChEMBL_ID
5381 PUBCHEM_CID
C086827 MESH_SUPPLEMENTAL_RECORD_UI
7328 INN_ID
DB00799 DRUGBANK_ID
81BDR9Y8PS UNII
6952 IUPHAR_LIGAND_ID
1293452 RXNORM
10196 MMSL
190198 MMSL
255259 MMSL
5542 MMSL
006668 NDDF
108906007 SNOMEDCT_US
386935009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 0023-0042 GEL 1 mg CUTANEOUS NDA 29 sections
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 0023-8335 GEL 0.50 mg CUTANEOUS NDA 29 sections
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 0023-9155 CREAM 0.50 mg CUTANEOUS NDA 26 sections
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 0023-9156 CREAM 1 mg CUTANEOUS NDA 26 sections
TAZAROTENE HUMAN PRESCRIPTION DRUG LABEL 1 0168-0454 CREAM 1 mg TOPICAL ANDA 26 sections
Tazarotene Cream HUMAN PRESCRIPTION DRUG LABEL 1 0168-0455 CREAM 1 mg TOPICAL ANDA 25 sections
Duobrii HUMAN PRESCRIPTION DRUG LABEL 2 0187-0653 LOTION 0.45 mg TOPICAL NDA 25 sections
Arazlo HUMAN PRESCRIPTION DRUG LABEL 1 0187-2098 LOTION 0.45 mg TOPICAL NDA 24 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 0713-0670 CREAM 1 mg TOPICAL ANDA 27 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 0713-0764 CREAM 1 mg TOPICAL ANDA 27 sections
Tazorac HUMAN PRESCRIPTION DRUG LABEL 1 16110-042 GEL 1 mg CUTANEOUS NDA 29 sections
Tazorac HUMAN PRESCRIPTION DRUG LABEL 1 16110-833 GEL 0.50 mg CUTANEOUS NDA 29 sections
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 16110-915 CREAM 0.05 mg CUTANEOUS NDA 29 sections
TAZORAC HUMAN PRESCRIPTION DRUG LABEL 1 16110-916 CREAM 0.10 mg CUTANEOUS NDA 29 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 51672-1373 CREAM 1 mg TOPICAL ANDA 27 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 51672-1374 CREAM 1 mg TOPICAL ANDA 27 sections
FABIOR HUMAN PRESCRIPTION DRUG LABEL 1 51862-295 AEROSOL, FOAM 1 mg TOPICAL NDA 27 sections
Tazorac HUMAN PRESCRIPTION DRUG LABEL 1 54868-4456 GEL 1 mg ORAL NDA 14 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 60758-556 CREAM 0.50 mg TOPICAL NDA 26 sections
Tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 60758-561 CREAM 1 mg TOPICAL NDA 26 sections
tazarotene HUMAN PRESCRIPTION DRUG LABEL 1 68308-685 AEROSOL, FOAM 1 mg TOPICAL NDA authorized generic 29 sections
CLINDAMYCIN 1% / NIACINULLMIDE 2% / TAZAROTENE 0.05% HUMAN PRESCRIPTION DRUG LABEL 3 72934-1050 GEL 0.05 g TOPICAL unapproved drug other 4 sections
NIACINULLMIDE 4% / TAZAROTENE 0.1% HUMAN PRESCRIPTION DRUG LABEL 2 72934-1161 GEL 0.10 g TOPICAL unapproved drug other 4 sections
HYALURONIC ACID SODIUM SALT 0.5% / TAZAROTENE 0.05% HUMAN PRESCRIPTION DRUG LABEL 2 72934-2093 CREAM 0.05 g TOPICAL unapproved drug other 4 sections
HYALURONIC ACID SODIUM SALT 0.5% / TAZAROTENE 0.1% HUMAN PRESCRIPTION DRUG LABEL 2 72934-2094 CREAM 0.10 g TOPICAL unapproved drug other 4 sections
NIACINULLMIDE 4% / TAZAROTENE 0.05% HUMAN PRESCRIPTION DRUG LABEL 2 72934-2160 CREAM 0.05 g TOPICAL unapproved drug other 4 sections
NIACINULLMIDE 4% / TAZAROTENE 0.1% HUMAN PRESCRIPTION DRUG LABEL 2 72934-2161 CREAM 0.10 g TOPICAL unapproved drug other 4 sections
011312 NIACINULLMIDE 4% / TAZAROTENE 0.05% HUMAN PRESCRIPTION DRUG LABEL 2 72934-2208 CREAM 0.05 g TOPICAL unapproved drug other 4 sections