FDA.reportPublic FDA data

Fentanyl Citrate

Product NDC
0641-6029
11-digit product format
006416029
Labeler code
0641
Product ID
0641-6029_546a047c-1faf-4751-9e48-079e4c35b6fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl Citrate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA019101
Marketing category
NDA
Marketing start
1984-07-11
Substance
FENTANYL CITRATE
Active strength
50 ug/mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fentanyl Citrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENTANYL CITRATE50 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMUN5LYG46H
Rxcui1735003, 1735007, 1735008, 1735013, 2168270, 2474269, 2629337

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
0641-6029-01Fentanyl Citrate20 mL in 1 VIALINJECTION2018
0641-6029-25Fentanyl Citrate25 in 1 CARTONINJECTION2518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6029-01ML - Milliliter0641-602917dfdee3-7df7-479e-b24a-1ed75980f77512013-02-13
0641-6029-25ML - Milliliter0641-6029c7086daf-3516-41bb-9413-11754f67ff6212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYL CITRATEACTIVE INGREDIENTMUN5LYG46HFENTANYL CITRATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
FENTANYLACTIVE MOIETYUF599785JZFENTANYL CITRATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFENTANYL CITRATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFENTANYL CITRATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RFENTANYL CITRATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6029FENTANYL CITRATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 2 package rows20250402_ce5db1c2-feb1-4ad2-847a-d02e865bd47e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2474269fentaNYL 0.05 MG in1 ML Prefilled SyringePSNce5db1c2-feb1-4ad2-847a-d02e865bd47e18
1735003fentaNYL citrate 100 MCG in 2 ML InjectionPSNce5db1c2-feb1-4ad2-847a-d02e865bd47e18
1735008fentaNYL citrate 1000 MCG in 20 ML InjectionPSNce5db1c2-feb1-4ad2-847a-d02e865bd47e18
2629337fentaNYL citrate 25 MCG in 0.5 ML Prefilled SyringePSNce5db1c2-feb1-4ad2-847a-d02e865bd47e18
1735007fentaNYL citrate 250 MCG in 5 ML InjectionPSNce5db1c2-feb1-4ad2-847a-d02e865bd47e18
1735013fentaNYL citrate 2500 MCG in 50 ML InjectionPSNce5db1c2-feb1-4ad2-847a-d02e865bd47e18
2168270fentaNYL citrate 50 MCG in 1 ML InjectionPSNce5db1c2-feb1-4ad2-847a-d02e865bd47e18
26293370.5 ML fentanyl 0.05 MG/ML Prefilled SyringeSCDce5db1c2-feb1-4ad2-847a-d02e865bd47e18
21682701 ML fentanyl 0.05 MG/ML InjectionSCDce5db1c2-feb1-4ad2-847a-d02e865bd47e18
24742691 ML fentanyl 0.05 MG/ML Prefilled SyringeSCDce5db1c2-feb1-4ad2-847a-d02e865bd47e18
17350032 ML fentanyl 0.05 MG/ML InjectionSCDce5db1c2-feb1-4ad2-847a-d02e865bd47e18
173500820 ML fentanyl 0.05 MG/ML InjectionSCDce5db1c2-feb1-4ad2-847a-d02e865bd47e18
17350075 ML fentanyl 0.05 MG/ML InjectionSCDce5db1c2-feb1-4ad2-847a-d02e865bd47e18
173501350 ML fentanyl 0.05 MG/ML InjectionSCDce5db1c2-feb1-4ad2-847a-d02e865bd47e18
2474269fentanyl (as fentanyl citrate) 0.05 MG per 1 ML Prefilled SyringeSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18
2629337fentanyl (as fentanyl citrate) 50 MCG/ML per 0.5 ML Prefilled SyringeSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18
2168270fentanyl (as fentanyl citrate) 50 MCG/ML per 1 ML InjectionSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18
1735003fentanyl (as fentanyl citrate) 50 MCG/ML per 2 ML InjectionSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18
1735008fentanyl (as fentanyl citrate) 50 MCG/ML per 20 ML InjectionSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18
1735007fentanyl (as fentanyl citrate) 50 MCG/ML per 5 ML InjectionSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18
1735013fentanyl (as fentanyl citrate) 50 MCG/ML per 50 ML InjectionSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18
2474269fentanyl 0.05 MG per 1 ML Prefilled SyringeSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18
1735003fentanyl citrate 100 MCG per 2 ML InjectionSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18
1735008fentanyl citrate 1000 MCG per 20 ML InjectionSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18
2629337fentanyl citrate 25 MCG per 0.5 ML Prefilled SyringeSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18
1735007fentanyl citrate 250 MCG per 5 ML InjectionSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18
1735013fentanyl citrate 2500 MCG per 50 ML InjectionSYce5db1c2-feb1-4ad2-847a-d02e865bd47e18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6029-010064160290120 mL in 1 VIAL (0641-6029-01) 20 ml1984-07-110000-00-00NoNoCurrent
0641-6029-250064160292525 VIAL in 1 CARTON (0641-6029-25) / 20 mL in 1 VIAL (0641-6029-01) 25 vial1984-07-110000-00-00NoNoCurrent