fentanyl citrate

Generic: fentanyl citrate

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fentanyl citrate
Generic Name fentanyl citrate
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

fentanyl citrate 50 ug/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-9094
Product ID 0409-9094_e4eaad6d-c21e-42fd-8fd9-f0b769966d61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019115
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2005-09-27

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04099094
Hyphenated Format 0409-9094

Supplemental Identifiers

RxCUI
1735003 1735004 1735006 1735007 1735008 1735013
UNII
MUN5LYG46H

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fentanyl citrate (source: ndc)
Generic Name fentanyl citrate (source: ndc)
Application Number NDA019115 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 ug/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-22) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-9094-12)
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-9094-18)
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-28) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9094-17)
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-31) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-9094-16)
  • 25 CARTON in 1 TRAY (0409-9094-61) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE (0409-9094-41)
source: ndc

Packages (5)

0409-9094-22 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-22) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-9094-12) 0409-9094-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-9094-18) 0409-9094-28 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-28) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9094-17) 0409-9094-31 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-31) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-9094-16) 0409-9094-61 25 CARTON in 1 TRAY (0409-9094-61) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE (0409-9094-41)

Ingredients (1)

fentanyl citrate (50 ug/mL)

Linked Drug Pages (2)

Fentanyl Citrate ndc-match (0.9) FENTANYL CITRATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "e4eaad6d-c21e-42fd-8fd9-f0b769966d61", "openfda": {"unii": ["MUN5LYG46H"], "rxcui": ["1735003", "1735004", "1735006", "1735007", "1735008", "1735013"], "spl_set_id": ["bfa8018a-4cbc-434b-e09e-782872b0340a"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-22)  / 2 mL in 1 VIAL, SINGLE-DOSE (0409-9094-12)", "package_ndc": "0409-9094-22", "marketing_start_date": "20101202"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-25)  / 5 mL in 1 VIAL, SINGLE-DOSE (0409-9094-18)", "package_ndc": "0409-9094-25", "marketing_start_date": "20051109"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-28)  / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9094-17)", "package_ndc": "0409-9094-28", "marketing_start_date": "20060217"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-31)  / 20 mL in 1 VIAL, SINGLE-DOSE (0409-9094-16)", "package_ndc": "0409-9094-31", "marketing_start_date": "20050927"}, {"sample": false, "description": "25 CARTON in 1 TRAY (0409-9094-61)  / 1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE (0409-9094-41)", "package_ndc": "0409-9094-61", "marketing_start_date": "20051222"}], "brand_name": "Fentanyl Citrate", "product_id": "0409-9094_e4eaad6d-c21e-42fd-8fd9-f0b769966d61", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0409-9094", "dea_schedule": "CII", "generic_name": "FENTANYL CITRATE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fentanyl Citrate", "active_ingredients": [{"name": "FENTANYL CITRATE", "strength": "50 ug/mL"}], "application_number": "NDA019115", "marketing_category": "NDA", "marketing_start_date": "20050927", "listing_expiration_date": "20271231"}