FDA.reportPublic FDA data

FENTANYL CITRATE

Product NDC
0409-9093
11-digit product format
004099093
Labeler code
0409
Product ID
0409-9093_5c5d5060-ba53-4e88-b390-f03217605d11
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
2016-12-06
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

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
0409-9093-31Fentanyl Citrate20 mL in 1 AMPULEINJECTION, SOLUTION2034
0409-9093-36Fentanyl Citrate5 in 1 CARTONINJECTION, SOLUTION534
0409-9093-38Fentanyl Citrate5 in 1 CARTONINJECTION, SOLUTION534
0409-9093-41Fentanyl Citrate10 mL in 1 AMPULEINJECTION, SOLUTION1034
0409-9093-09FENTANYL CITRATE2 mL in 1 AMPULEINJECTION, SOLUTION217
0409-9093-11FENTANYL CITRATE10 in 1 CELLO PACKINJECTION, SOLUTION1017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-9093-09ML - Milliliter0409-90938c8321a0-3a3e-493a-b63a-11f80fd01a4812017-07-07
0409-9093-11ML - Milliliter0409-909316546039-6629-4e19-b1b6-43e72476ac0012016-10-06
0409-9093-31ML - Milliliter0409-90931b9f421f-17ca-4cb3-a035-7adf8613d85e12016-11-08
0409-9093-32ML - Milliliter0409-909362ea0a31-4874-41d0-a37c-3b0d397dc93612012-07-24
0409-9093-35ML - Milliliter0409-90932af7c812-df49-48a5-a0f8-973fcf8b434212012-07-24
0409-9093-36ML - Milliliter0409-909301bdba66-d141-4125-a15d-9015f35b45af12012-07-24
0409-9093-37ML - Milliliter0409-9093414272bc-a96d-4c75-9cd3-b9c3b60e915e12017-06-15
0409-9093-38ML - Milliliter0409-909392ad221b-5202-48d1-9a0d-c632d6f491f712012-07-24
0409-9093-45ML - Milliliter0409-90934338066a-618f-4375-bfd2-d3954f67eb1412017-06-15

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
0409-9093FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.]32Current NDC, Legacy NDC, 4 package rows20250122_bfa8018a-4cbc-434b-e09e-782872b0340a.zip
0409-9093FENTANYL 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
0409-9093-09004099093092 mL in 1 AMPULE2 mlHistorical
0409-9093-110040990931110 AMPULE in 1 CELLO PACK (0409-9093-11) / 2 mL in 1 AMPULE (0409-9093-09) 10 ampule2016-12-060000-00-00NoNoCurrent
0409-9093-310040990933120 mL in 1 AMPULE20 mlHistorical
0409-9093-320040990933210 AMPULE in 1 CELLO PACK (0409-9093-32) > 2 mL in 1 AMPULE (0409-9093-37) 10 ampule2005-11-150000-00-00NoNoCurrent
0409-9093-350040990933510 AMPULE in 1 CELLO PACK (0409-9093-35) > 5 mL in 1 AMPULE (0409-9093-45) 10 ampule2005-12-140000-00-00NoNoCurrent
0409-9093-36004099093365 in 1 CARTONHistorical
0409-9093-38004099093385 in 1 CARTONHistorical
0409-9093-410040990934110 mL in 1 AMPULE10 mlHistorical