FDA.reportPublic FDA data

Fentanyl Citrate

Product NDC
0093-7867
11-digit product format
000937867
Labeler code
0093
Product ID
0093-7867_fbd13f54-5afe-4acc-afa6-2dfa78704003
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl Citrate
Dosage form
LOZENGE
Route
ORAL; TRANSMUCOSAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
NDA020747
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-12-08
Marketing end
0000-00-00
Substance
FENTANYL CITRATE
Active strength
600 ug/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
739fa0ac-b690-63c4-9904-e20dffbf78f9Product name120140508
7763fcbb-367d-ed06-b37f-e1529b6241beProduct name120140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7867-19Fentanyl Citrate1 in 1 BLISTER PACKLOZENGE116
0093-7867-65Fentanyl Citrate30 in 1 CARTONLOZENGE3016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7867FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA, INC.]15Legacy NDC, 2 package rows20241018_78221eab-66fd-4cd8-9c81-af52eb83671c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310293fentaNYL citrate 1200 MCG Oral LozengePSN78221eab-66fd-4cd8-9c81-af52eb83671c16
310294fentaNYL citrate 1600 MCG Oral LozengePSN78221eab-66fd-4cd8-9c81-af52eb83671c16
310295fentaNYL citrate 200 MCG Oral LozengePSN78221eab-66fd-4cd8-9c81-af52eb83671c16
310297fentaNYL citrate 400 MCG Oral LozengePSN78221eab-66fd-4cd8-9c81-af52eb83671c16
313992fentaNYL citrate 600 MCG Oral LozengePSN78221eab-66fd-4cd8-9c81-af52eb83671c16
313993fentaNYL citrate 800 MCG Oral LozengePSN78221eab-66fd-4cd8-9c81-af52eb83671c16
310295fentanyl 0.2 MG Oral LozengeSCD78221eab-66fd-4cd8-9c81-af52eb83671c16
310297fentanyl 0.4 MG Oral LozengeSCD78221eab-66fd-4cd8-9c81-af52eb83671c16
313992fentanyl 0.6 MG Oral LozengeSCD78221eab-66fd-4cd8-9c81-af52eb83671c16
313993fentanyl 0.8 MG Oral LozengeSCD78221eab-66fd-4cd8-9c81-af52eb83671c16
310293fentanyl 1.2 MG Oral LozengeSCD78221eab-66fd-4cd8-9c81-af52eb83671c16
310294fentanyl 1.6 MG Oral LozengeSCD78221eab-66fd-4cd8-9c81-af52eb83671c16
310293fentanyl (as fentanyl citrate) 1200 MCG Oral LozengeSY78221eab-66fd-4cd8-9c81-af52eb83671c16
310294fentanyl (as fentanyl citrate) 1600 MCG Oral LozengeSY78221eab-66fd-4cd8-9c81-af52eb83671c16
310295fentanyl (as fentanyl citrate) 200 MCG Oral LozengeSY78221eab-66fd-4cd8-9c81-af52eb83671c16
310297fentanyl (as fentanyl citrate) 400 MCG Oral LozengeSY78221eab-66fd-4cd8-9c81-af52eb83671c16
313992fentanyl (as fentanyl citrate) 600 MCG Oral LozengeSY78221eab-66fd-4cd8-9c81-af52eb83671c16
313993fentanyl (as fentanyl citrate) 800 MCG Oral LozengeSY78221eab-66fd-4cd8-9c81-af52eb83671c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7867-19000937867191 in 1 BLISTER PACKHistorical
0093-7867-650009378676530 BLISTER PACK in 1 CARTON (0093-7867-65) > 1 LOZENGE in 1 BLISTER PACK (0093-7867-19) 30 blister pack2015-12-080000-00-00NoNoCurrent