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 0409-9093
Product ID 0409-9093_8ade1d73-b442-4cf5-82a6-be3120bbf33a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019115
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-12-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04099093
Hyphenated Format 0409-9093

Supplemental Identifiers

RxCUI
1735003
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
  • 10 AMPULE in 1 CELLO PACK (0409-9093-11) / 2 mL in 1 AMPULE (0409-9093-09)
source: ndc

Packages (1)

0409-9093-11 10 AMPULE in 1 CELLO PACK (0409-9093-11) / 2 mL in 1 AMPULE (0409-9093-09)

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": "8ade1d73-b442-4cf5-82a6-be3120bbf33a", "openfda": {"unii": ["MUN5LYG46H"], "rxcui": ["1735003"], "spl_set_id": ["1ed25b2c-334e-4021-ada1-3396f07630dc"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 CELLO PACK (0409-9093-11)  / 2 mL in 1 AMPULE (0409-9093-09)", "package_ndc": "0409-9093-11", "marketing_start_date": "20161206"}], "brand_name": "FENTANYL CITRATE", "product_id": "0409-9093_8ade1d73-b442-4cf5-82a6-be3120bbf33a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0409-9093", "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": "20161206", "listing_expiration_date": "20261231"}