FDA.reportPublic FDA data

Fentanyl Citrate

Product NDC
63323-810
11-digit product format
633230810
Labeler code
63323
Product ID
63323-810_a47a3a31-e293-49d5-b6bc-950303525a64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl Citrate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA212086
Marketing category
ANDA
Marketing start
2021-01-15
Substance
FENTANYL CITRATE
Active strength
100 ug/2mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fentanyl Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENTANYL CITRATE100 ug/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMUN5LYG46H
Rxcui2474267, 2474269

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-810-00Fentanyl Citrate2 mL in 1 SYRINGEINJECTION, SOLUTION26
63323-810-20Fentanyl Citrate20 in 1 CARTONINJECTION, SOLUTION206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-810-00ML - Milliliter63323-8100b746c2d-239a-4cf1-a567-8bf823a278fb12023-07-06
63323-810-20ML - Milliliter63323-81071c8df47-2813-431d-afb6-8996a0c02d3112023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-810FENTANYL CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, 2 package rows20240117_0c10e465-4117-48ba-a454-23ccb7a3fcc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2474269fentaNYL 0.05 MG in1 ML Prefilled SyringePSN0c10e465-4117-48ba-a454-23ccb7a3fcc76
2474267fentaNYL 100 MCG in 2 ML Prefilled SyringePSN0c10e465-4117-48ba-a454-23ccb7a3fcc76
24742691 ML fentanyl 0.05 MG/ML Prefilled SyringeSCD0c10e465-4117-48ba-a454-23ccb7a3fcc76
24742672 ML fentanyl 0.05 MG/ML Prefilled SyringeSCD0c10e465-4117-48ba-a454-23ccb7a3fcc76
2474269fentanyl (as fentanyl citrate) 0.05 MG per 1 ML Prefilled SyringeSY0c10e465-4117-48ba-a454-23ccb7a3fcc76
2474267fentanyl (as fentanyl citrate) 100 MCG per 2 ML Prefilled SyringeSY0c10e465-4117-48ba-a454-23ccb7a3fcc76
2474269fentanyl 0.05 MG per 1 ML Prefilled SyringeSY0c10e465-4117-48ba-a454-23ccb7a3fcc76
2474267fentanyl 100 MCG per 2 ML Prefilled SyringeSY0c10e465-4117-48ba-a454-23ccb7a3fcc76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63323-810-00633230810002 mL in 1 SYRINGE2 mlHistorical
63323-810-206332308102020 SYRINGE in 1 CARTON (63323-810-20) / 2 mL in 1 SYRINGE (63323-810-00) 20 syringe2023-02-17NoNoCurrent