FDA.reportPublic FDA data

Fentanyl Citrate

Manufacturer
Cantrell Drug Company
Effective date
2014-05-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 20:18:35

Label at a glance#

ProductFentanyl Citrate
Active ingredientFentanyl Citrate
Label structure1 sections

Label contents#

Full prescribing information#

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1735004fentanyl 0.05 MG/ML InjectionSCD5
1735004fentanyl (as fentanyl citrate) 0.05 MG/ML InjectionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FENTANYL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3Product name120231002
a8df478d-5b88-9654-981b-87dff14dda8bProduct name220190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57Product name220180118
bb365072-425e-ca0a-021e-fd8b78162502Product name220161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6Product name220160104
739fa0ac-b690-63c4-9904-e20dffbf78f9Product name120140508
7763fcbb-367d-ed06-b37f-e1529b6241beProduct name120140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52533-074-162019-11-27C16284748780-19855e2a2-3a26-60a7-e053-dbdaa90a05bdFentanyl Citrate 50 mcg/mL in Sterile Water 2 mL Syringe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52533-074-16Fentanyl Citrate2 mL in 1 SYRINGEINJECTION, SOLUTION25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52533-074FENTANYL CITRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]5Legacy NDC, 1 package rows20140503_73cede3f-aff0-40b8-8a58-f5fc269d1b8d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52533-074-15ML - Milliliter52533-0740a97fc18-b3d5-42a7-b5d0-9353370b690212015-10-02
52533-074-16ML - Milliliter52533-07401ad414c-438f-4203-8082-97f04cbeb01a12015-10-02
52533-074-39ML - Milliliter52533-074f98086c4-1eac-44cc-adf4-671a0399865612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Fentanyl CitrateACTIVE INGREDIENTMUN5LYG46H5
FentanylACTIVE MOIETYUF599785JZ5
WaterINACTIVE INGREDIENT059QF0KO0R5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52533-07452533-074-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Fentanyl CitrateMUN5LYG46HACTIM
Water059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBCNTM
SODIUM HYDROXIDE55X04QC32ICNTM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d4c18576-18ff-46c1-99fa-8b88ef32b86e73cede3f-aff0-40b8-8a58-f5fc269d1b8d2014-05-02Exact identifier
spl id: d4c18576-18ff-46c1-99fa-8b88ef32b86e
spl set id: 73cede3f-aff0-40b8-8a58-f5fc269d1b8d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.