FDA.reportPublic FDA data

NDC 0409-9094-17 - Fentanyl Citrate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0409-9094
Requested NDC
0409-9094-17
Package NDCs from labels
0409-9094-12, 0409-9094-22, 0409-9094-18, 0409-9094-25, 0409-9094-17, 0409-9094-28, 0409-9094-16, 0409-9094-31, 0409-9094-41, 0409-9094-61, 0409-9094-44, 0409-9094-55, 0409-9094-09, 0409-9094-11
Manufacturer
Hospira, Inc.
Effective date
2026-08-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fentanyl Citrate - Hospira, Inc.Hospira, Inc.2026-08-24HUMAN PRESCRIPTION DRUG LABEL
FENTANYL CITRATE - Hospira, Inc.Hospira, Inc.2026-04-07HUMAN PRESCRIPTION DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 11 · 201 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fentanyl CitrateFENTANYL CITRATEHospira, Inc.bfa8018a-4cbc-434b-e09e-782872b0340a2026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019115
ndc (package): 0409-9094-17
ndc (package): 0409-9094-61
ndc (package): 0409-9094-31
ndc (package): 0409-9094-22
ndc (package): 0409-9094-44
ndc (package): 0409-9094-28
ndc (package): 0409-9094-16
ndc (package): 0409-9093-31
ndc (package): 0409-9094-25
ndc (package): 0409-9094-12
ndc (package): 0409-9093-36
ndc (package): 0409-9094-55
ndc (package): 0409-9093-41
ndc (package): 0409-9093-38
ndc (package): 0409-9094-41
ndc (package): 0409-9094-18
ndc (product): 0409-9093
ndc (product): 0409-9094
ndc11 (package): 00409909417
rxcui: 1735008
rxcui: 1735004
rxcui: 1735006
rxcui: 1735003
rxcui: 1735007
rxcui: 1735013
spl id: 8ff8b8cf-1a31-46dc-b350-2b9cc700e6a6
spl set id: bfa8018a-4cbc-434b-e09e-782872b0340a
unii: MUN5LYG46H
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Humalog KwikPenINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.