FDA.reportPublic FDA data

FENTANYL

Substance profile for UNII UF599785JZ, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for FENTANYL
Structure render from PubChem CID 3345

Substance Identity#

UNII
UF599785JZ
Preferred term
FENTANYL
Registry number
437-38-7
EC number
207-113-6
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C22H28N2O
Chemical structure for FENTANYL
Structure render from PubChem CID 3345

Chemical And Database Identifiers#

InChIKey
PJMPHNIQZUBGLI-UHFFFAOYSA-N
SMILES
CCC(=O)N(C1CCN(CCC2=CC=CC=C2)CC1)C3=CC=CC=C3
RxCUI
4337
PubChem
3345
NCIt
C494
INN ID
1608

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound3345pubchem.ncbi.nlm.nih.gov/compound/3345
PubChem InChIKey SearchPJMPHNIQZUBGLI-UHFFFAOYSA-Npubchem.ncbi.nlm.nih.gov/#query=PJMPHNIQZUBGLI-UHFFFAOYSA-N
RxNorm4337mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=4337
NCI ThesaurusC494ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C494
FDA Substance Registration SystemUF599785JZprecision.fda.gov/uniisearch/srs/unii/UF599785JZ
European Community number207-113-6commonchemistry.cas.org/results?q=207-113-6

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE MOIETYFentanyl Citrate 1 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Bag6
ACTIVE MOIETYFentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Bag5
ACTIVE MOIETYFentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 125 mL Bag2
ACTIVE MOIETYThese highlights do not include all the information needed to use ABSTRAL safely and effectively. See full prescribing information for ABSTRAL. ABSTRAL ® (fentanyl) sublingual tablets CII Initial U.S. Approval: 19682
ACTIVE INGREDIENTFENTANYL transdermal system, CII These highlights do not include all the information needed to use Fentanyl safely and effectively. See full prescribing information for Fentanyl. Fentanyl (Fentanyl) PATCH for TRANSDERMAL use. Initial U.S. Approval: 19684
ACTIVE MOIETYFENTANYL transdermal system, CII These highlights do not include all the information needed to use Fentanyl safely and effectively. See full prescribing information for Fentanyl. Fentanyl (Fentanyl) PATCH for TRANSDERMAL use. Initial U.S. Approval: 19684
ACTIVE MOIETYFentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 250 mL Bag8
ACTIVE MOIETYFentanyl Citrate 5 mcg/mL in 0.9% Sodium Chloride 3 mL Syringe4
ACTIVE MOIETYFentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 250 mL Bag3
ACTIVE MOIETYFentanyl Citrate 3 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 200 mL Bag5
ACTIVE MOIETYFentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet1
ACTIVE MOIETYFentanyl Citrate 50 mcg/mL in Sterile Water 2 mL Syringe5
ACTIVE MOIETYFentanyl Citrate 50 mcg/mL in Sterile Water 5 mL Syringe5
ACTIVE MOIETYFentanyl Citrate 50 mcg/mL in Sterile Water 20 mL Syringe6
ACTIVE MOIETYFentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 100 mL Bag3
ACTIVE MOIETYFentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial1
ACTIVE MOIETYThese highlights do not include all the information needed to use LAZANDA safely and effectively. See full prescribing information for LAZANDA Lazanda ® (Fentanyl) Nasal Spray CII Initial U.S. Approval: 19685
ACTIVE MOIETYThese highlights do not include all the information needed to use ABSTRAL safely and effectively. See full prescribing information for ABSTRAL. ABSTRAL ® (fentanyl) sublingual tablets CII Initial U.S. Approval: 19683
ACTIVE INGREDIENTFentanyl Transdermal System C-II Revised: August 2008 Rx only4
ACTIVE MOIETYFentanyl Transdermal System C-II Revised: August 2008 Rx only4
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM CII3
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM CII3
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM CII3
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM CII3
ACTIVE MOIETYFentanyl Transdermal System C-II Revised: August 2008 Rx only3444
ACTIVE INGREDIENTFentanyl Transdermal System C-II Revised: August 2008 Rx only3444
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr CII Full Prescribing Information Rx only FOR USE IN OPIOID-TOLERANT PATIENTS ONLY1
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr CII Full Prescribing Information Rx only FOR USE IN OPIOID-TOLERANT PATIENTS ONLY1
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr CII Full Prescribing Information Rx only FOR USE IN OPIOID-TOLERANT PATIENTS ONLY1
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr CII Full Prescribing Information Rx only FOR USE IN OPIOID-TOLERANT PATIENTS ONLY1
ACTIVE MOIETYThese highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC. Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 19681
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM CII1
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM CII1
ACTIVE MOIETYThese highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC. Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 19682
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM CII Rx only1
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM CII Rx only1
ACTIVE INGREDIENTb7fe401c-7ddc-4391-9cff-3608da03e86b2
ACTIVE MOIETYb7fe401c-7ddc-4391-9cff-3608da03e86b2
ACTIVE MOIETYSUBLIMAZE ® Injection CII1
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3443
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3443
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
ACTIVE MOIETYFENTANYL PATCH [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL PATCH [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]26
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]26
ACTIVE INGREDIENTFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [MALLINCKRODT, INC.]25
ACTIVE MOIETYFENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [MALLINCKRODT, INC.]25
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.]16
ACTIVE MOIETYFENTANYL CITRATE LOZENGE [CIMA LABS INC.]12
ACTIVE INGREDIENTSUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
ACTIVE MOIETYSUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
ACTIVE MOIETYFENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]11
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.]11
ACTIVE MOIETYFENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.]10
ACTIVE INGREDIENTFENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]9
ACTIVE MOIETYFENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]9
ACTIVE INGREDIENTDURAGESIC (FENTANYL) PATCH [JANSSEN PHARMACEUTICALS, INC.]8
ACTIVE MOIETYDURAGESIC (FENTANYL) PATCH [JANSSEN PHARMACEUTICALS, INC.]8
ACTIVE MOIETYFENTANYL PATCH [SANDOZ,INC.]8
ACTIVE INGREDIENTFENTANYL PATCH [SANDOZ,INC.]8
ACTIVE MOIETYACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]7
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]6
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
ACTIVE INGREDIENTFENTANYL - NOVAPLUS (FENTANYL) PATCH, EXTENDED RELEASE [WATSON LABORATORIES, INC.]5
ACTIVE MOIETYFENTANYL - NOVAPLUS (FENTANYL) PATCH, EXTENDED RELEASE [WATSON LABORATORIES, INC.]5
ACTIVE MOIETYFENTANYL BUCCAL TABLET [WATSON LABORATORIES, INC.]5
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]5
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]5
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]5
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]4
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]4
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]4
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]4
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]4
ACTIVE MOIETYFENTANYL CITRATE LOZENGE [PAR PHARMACEUTICAL INC.]4
ACTIVE MOIETYFENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]4
ACTIVE INGREDIENTFENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]4
ACTIVE MOIETYFENTANYL CITRATE INJECTION [AKORN, INC.]3
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]3
ACTIVE MOIETYFENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]3