fentanyl citrate

Generic: fentanyl citrate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fentanyl citrate
Generic Name fentanyl citrate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

fentanyl citrate 100 ug/2mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-810
Product ID 63323-810_a47a3a31-e293-49d5-b6bc-950303525a64
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212086
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-01-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323810
Hyphenated Format 63323-810

Supplemental Identifiers

RxCUI
2474267 2474269
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 ANDA212086 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/2mL
source: ndc
Packaging
  • 20 SYRINGE in 1 CARTON (63323-810-20) / 2 mL in 1 SYRINGE (63323-810-00)
source: ndc

Packages (1)

63323-810-20 20 SYRINGE in 1 CARTON (63323-810-20) / 2 mL in 1 SYRINGE (63323-810-00)

Ingredients (1)

fentanyl citrate (100 ug/2mL)

Linked Drug Pages (1)

Fentanyl Citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "a47a3a31-e293-49d5-b6bc-950303525a64", "openfda": {"unii": ["MUN5LYG46H"], "rxcui": ["2474267", "2474269"], "spl_set_id": ["0c10e465-4117-48ba-a454-23ccb7a3fcc7"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 SYRINGE in 1 CARTON (63323-810-20)  / 2 mL in 1 SYRINGE (63323-810-00)", "package_ndc": "63323-810-20", "marketing_start_date": "20230217"}], "brand_name": "Fentanyl Citrate", "product_id": "63323-810_a47a3a31-e293-49d5-b6bc-950303525a64", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63323-810", "dea_schedule": "CII", "generic_name": "Fentanyl Citrate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fentanyl Citrate", "active_ingredients": [{"name": "FENTANYL CITRATE", "strength": "100 ug/2mL"}], "application_number": "ANDA212086", "marketing_category": "ANDA", "marketing_start_date": "20210115", "listing_expiration_date": "20261231"}