FDA.reportPublic FDA data

Fentanyl Citrate

Product NDC
0409-9094
11-digit product format
004099094
Labeler code
0409
Product ID
0409-9094_e4eaad6d-c21e-42fd-8fd9-f0b769966d61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENTANYL CITRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA019115
Marketing category
NDA
Marketing start
2005-09-27
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, 1735004, 1735006, 1735007, 1735008, 1735013

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
0409-9094-12Fentanyl Citrate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION234
0409-9094-16Fentanyl Citrate20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2034
0409-9094-17Fentanyl Citrate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1034
0409-9094-18Fentanyl Citrate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION534
0409-9094-22Fentanyl Citrate25 in 1 TRAYINJECTION, SOLUTION2534
0409-9094-25Fentanyl Citrate25 in 1 TRAYINJECTION, SOLUTION2534
0409-9094-28Fentanyl Citrate25 in 1 TRAYINJECTION, SOLUTION2534
0409-9094-31Fentanyl Citrate25 in 1 TRAYINJECTION, SOLUTION2534
0409-9094-41Fentanyl Citrate50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION5034
0409-9094-61Fentanyl Citrate25 in 1 TRAYINJECTION, SOLUTION2534
0409-9094-61Fentanyl Citrate1 in 1 CARTONINJECTION, SOLUTION134
0409-9094-09FENTANYL CITRATE2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION217
0409-9094-11FENTANYL CITRATE25 in 1 TRAYINJECTION, SOLUTION2517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-9094-09ML - Milliliter0409-909478e41391-df08-4457-a6ca-a8be28d8336312017-03-06
0409-9094-11ML - Milliliter0409-90940f2dbddd-e80e-4813-b52b-268e658e484b12016-10-06
0409-9094-12ML - Milliliter0409-9094087cf73e-6280-406f-a48c-635a8d47250412017-03-06
0409-9094-16ML - Milliliter0409-9094655dfca1-6b6c-4e4a-bd07-22365e54421e12017-06-15
0409-9094-17ML - Milliliter0409-9094665187c5-67fe-4d49-b540-16fa934ab94712017-06-15
0409-9094-18ML - Milliliter0409-90941b21ec53-076c-44cd-bfc1-41b11497087b12017-06-15
0409-9094-22ML - Milliliter0409-9094e36a4e8a-a968-4a1c-bdf5-d13a5ec0372d12012-07-24
0409-9094-25ML - Milliliter0409-9094237638dd-764f-44c1-a2e4-c884aa9132e212012-07-24
0409-9094-28ML - Milliliter0409-90940185a1e2-9ac4-4d45-9f2a-d8bd43670b9c12012-07-24
0409-9094-31ML - Milliliter0409-909487c44609-6553-4f05-8a70-9c932182260c12012-07-24
0409-9094-41ML - Milliliter0409-90949966f586-f017-41ea-85e1-83ede9a9f28112016-10-06
0409-9094-61ML - Milliliter0409-90942ef8ca16-b335-494a-9318-220db507f9b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYL CITRATEACTIVE INGREDIENTMUN5LYG46HFENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.]11
FENTANYLACTIVE MOIETYUF599785JZFENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.]11
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.]11
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RFENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-9094FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.]32Current NDC, Legacy NDC, 11 package rows20250122_bfa8018a-4cbc-434b-e09e-782872b0340a.zip
0409-9094FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.]16Current NDC, Legacy NDC, 2 package rows20241123_1ed25b2c-334e-4021-ada1-3396f07630dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1735003fentaNYL citrate 100 MCG in 2 ML InjectionPSNbfa8018a-4cbc-434b-e09e-782872b0340a34
1735008fentaNYL citrate 1000 MCG in 20 ML InjectionPSNbfa8018a-4cbc-434b-e09e-782872b0340a34
1735007fentaNYL citrate 250 MCG in 5 ML InjectionPSNbfa8018a-4cbc-434b-e09e-782872b0340a34
1735013fentaNYL citrate 2500 MCG in 50 ML InjectionPSNbfa8018a-4cbc-434b-e09e-782872b0340a34
1735006fentaNYL citrate 500 MCG in 10 ML InjectionPSNbfa8018a-4cbc-434b-e09e-782872b0340a34
173500610 ML fentanyl 0.05 MG/ML InjectionSCDbfa8018a-4cbc-434b-e09e-782872b0340a34
17350032 ML fentanyl 0.05 MG/ML InjectionSCDbfa8018a-4cbc-434b-e09e-782872b0340a34
173500820 ML fentanyl 0.05 MG/ML InjectionSCDbfa8018a-4cbc-434b-e09e-782872b0340a34
17350075 ML fentanyl 0.05 MG/ML InjectionSCDbfa8018a-4cbc-434b-e09e-782872b0340a34
173501350 ML fentanyl 0.05 MG/ML InjectionSCDbfa8018a-4cbc-434b-e09e-782872b0340a34
1735004fentanyl 0.05 MG/ML InjectionSCDbfa8018a-4cbc-434b-e09e-782872b0340a34
1735004fentanyl (as fentanyl citrate) 0.05 MG/ML InjectionSYbfa8018a-4cbc-434b-e09e-782872b0340a34
1735006fentanyl (as fentanyl citrate) 50 MCG/ML per 10 ML InjectionSYbfa8018a-4cbc-434b-e09e-782872b0340a34
1735003fentanyl (as fentanyl citrate) 50 MCG/ML per 2 ML InjectionSYbfa8018a-4cbc-434b-e09e-782872b0340a34
1735008fentanyl (as fentanyl citrate) 50 MCG/ML per 20 ML InjectionSYbfa8018a-4cbc-434b-e09e-782872b0340a34
1735007fentanyl (as fentanyl citrate) 50 MCG/ML per 5 ML InjectionSYbfa8018a-4cbc-434b-e09e-782872b0340a34
1735013fentanyl (as fentanyl citrate) 50 MCG/ML per 50 ML InjectionSYbfa8018a-4cbc-434b-e09e-782872b0340a34
1735003fentanyl citrate 100 MCG per 2 ML InjectionSYbfa8018a-4cbc-434b-e09e-782872b0340a34
1735008fentanyl citrate 1000 MCG per 20 ML InjectionSYbfa8018a-4cbc-434b-e09e-782872b0340a34
1735007fentanyl citrate 250 MCG per 5 ML InjectionSYbfa8018a-4cbc-434b-e09e-782872b0340a34
1735013fentanyl citrate 2500 MCG per 50 ML InjectionSYbfa8018a-4cbc-434b-e09e-782872b0340a34
1735006fentanyl citrate 500 MCG per 10 ML InjectionSYbfa8018a-4cbc-434b-e09e-782872b0340a34
1735003fentaNYL citrate 100 MCG in 2 ML InjectionPSN1ed25b2c-334e-4021-ada1-3396f07630dc17
17350032 ML fentanyl 0.05 MG/ML InjectionSCD1ed25b2c-334e-4021-ada1-3396f07630dc17
1735003fentanyl (as fentanyl citrate) 50 MCG/ML per 2 ML InjectionSY1ed25b2c-334e-4021-ada1-3396f07630dc17
1735003fentanyl citrate 100 MCG per 2 ML InjectionSY1ed25b2c-334e-4021-ada1-3396f07630dc17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-9094-09004099094092 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0409-9094-110040990941125 in 1 TRAYHistorical
0409-9094-12004099094122 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0409-9094-160040990941620 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
0409-9094-170040990941710 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
0409-9094-18004099094185 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0409-9094-220040990942225 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-22) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-9094-12) 2010-12-020000-00-00NoNoCurrent
0409-9094-250040990942525 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-9094-18) 2005-11-090000-00-00NoNoCurrent
0409-9094-280040990942825 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-28) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9094-17) 2006-02-170000-00-00NoNoCurrent
0409-9094-310040990943125 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-31) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-9094-16) 2005-09-270000-00-00NoNoCurrent
0409-9094-410040990944150 mL in 1 VIAL, SINGLE-DOSE50 mlHistorical
0409-9094-610040990946125 CARTON in 1 TRAY (0409-9094-61) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE (0409-9094-41) 25 carton2005-12-220000-00-00NoNoCurrent