FDA.reportPublic FDA data

Transmucosal Fentanyl Citrate

Product NDC
52959-566
11-digit product format
529590566
Labeler code
52959
Product ID
52959-566_319f79f5-a83e-4c51-b362-c01eb43d5ed6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fentanyl citrate
Dosage form
LOZENGE
Route
ORAL; TRANSMUCOSAL
Labeler
H.J. Harkins Company, Inc.
Application
NDA020747
Marketing category
NDA
Marketing start
2006-09-06
Marketing end
0000-00-00
Substance
FENTANYL CITRATE
Active strength
1200 1/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
52959-566-302019-11-13C16284748780-197449f38-b5c1-f6ea-e053-dbdaa90aa703These 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: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-566-01Transmucosal Fentanyl Citrate1 in 1 BLISTER PACKLOZENGE11
52959-566-30Transmucosal Fentanyl Citrate30 in 1 CARTONLOZENGE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-566-30EA - Each52959-5667ac4f00c-bf56-48ef-9fce-be90a468285f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYL CITRATEACTIVE INGREDIENTMUN5LYG46HTRANSMUCOSAL FENTANYL CITRATE (FENTANYL CITRATE) LOZENGE [H.J. HARKINS COMPANY, INC.]1
FENTANYLACTIVE MOIETYUF599785JZTRANSMUCOSAL FENTANYL CITRATE (FENTANYL CITRATE) LOZENGE [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-566TRANSMUCOSAL FENTANYL CITRATE (FENTANYL CITRATE) LOZENGE [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 2 package rows20111216_e4ce209d-3f8c-4ac4-bec1-2525a93708bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310293fentaNYL citrate 1200 MCG Oral LozengePSNe4ce209d-3f8c-4ac4-bec1-2525a93708bc1
310297fentaNYL citrate 400 MCG Oral LozengePSNe4ce209d-3f8c-4ac4-bec1-2525a93708bc1
313992fentaNYL citrate 600 MCG Oral LozengePSNe4ce209d-3f8c-4ac4-bec1-2525a93708bc1
310297fentanyl 0.4 MG Oral LozengeSCDe4ce209d-3f8c-4ac4-bec1-2525a93708bc1
313992fentanyl 0.6 MG Oral LozengeSCDe4ce209d-3f8c-4ac4-bec1-2525a93708bc1
310293fentanyl 1.2 MG Oral LozengeSCDe4ce209d-3f8c-4ac4-bec1-2525a93708bc1
310293fentanyl (as fentanyl citrate) 1200 MCG Oral LozengeSYe4ce209d-3f8c-4ac4-bec1-2525a93708bc1
310297fentanyl (as fentanyl citrate) 400 MCG Oral LozengeSYe4ce209d-3f8c-4ac4-bec1-2525a93708bc1
313992fentanyl (as fentanyl citrate) 600 MCG Oral LozengeSYe4ce209d-3f8c-4ac4-bec1-2525a93708bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-566-01529590566011 in 1 BLISTER PACKHistorical
52959-566-305295905663030 in 1 CARTONHistorical