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 .05 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-806
Product ID 63323-806_341b092a-1f6f-40f1-98f2-9346bf2e1242
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210762
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-05-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323806
Hyphenated Format 63323-806

Supplemental Identifiers

RxCUI
1735003 1735007 1735008 1735013 2168270
UPC
0363323806132 0363323806149 0363323806507
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 ANDA210762 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .05 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-806-11)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-806-12)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-806-13)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-806-14)
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-50) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (5)

63323-806-01 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-806-11) 63323-806-02 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-806-12) 63323-806-05 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-806-13) 63323-806-20 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-806-14) 63323-806-50 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-50) / 50 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

fentanyl citrate (.05 mg/mL)

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": "341b092a-1f6f-40f1-98f2-9346bf2e1242", "openfda": {"upc": ["0363323806132", "0363323806149", "0363323806507"], "unii": ["MUN5LYG46H"], "rxcui": ["1735003", "1735007", "1735008", "1735013", "2168270"], "spl_set_id": ["38d0c14a-a0c1-44cc-a939-0304eb8037d6"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-806-11)", "package_ndc": "63323-806-01", "marketing_start_date": "20190503"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-02)  / 2 mL in 1 VIAL, SINGLE-DOSE (63323-806-12)", "package_ndc": "63323-806-02", "marketing_start_date": "20190503"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-05)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-806-13)", "package_ndc": "63323-806-05", "marketing_start_date": "20190503"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-20)  / 20 mL in 1 VIAL, SINGLE-DOSE (63323-806-14)", "package_ndc": "63323-806-20", "marketing_start_date": "20190503"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-50)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-806-50", "marketing_start_date": "20190503"}], "brand_name": "Fentanyl Citrate", "product_id": "63323-806_341b092a-1f6f-40f1-98f2-9346bf2e1242", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63323-806", "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": ".05 mg/mL"}], "application_number": "ANDA210762", "marketing_category": "ANDA", "marketing_start_date": "20190503", "listing_expiration_date": "20261231"}