fentanyl citrate

Generic: fentanyl citrate

Labeler: phlow corp.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fentanyl citrate
Generic Name fentanyl citrate
Labeler phlow corp.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

fentanyl citrate 50 ug/mL

Manufacturer
Phlow Corp.

Identifiers & Regulatory

Product NDC 81565-205
Product ID 81565-205_bec14279-d399-4bc5-8f6c-e397d6532ba5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019101
DEA Schedule cii
Marketing Start 2023-01-11
Marketing End 2028-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81565205
Hyphenated Format 81565-205

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 NDA019101 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 ug/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (81565-205-02) / 2 mL in 1 VIAL (81565-205-01)
source: ndc

Packages (1)

81565-205-02 25 VIAL in 1 CARTON (81565-205-02) / 2 mL in 1 VIAL (81565-205-01)

Ingredients (1)

fentanyl citrate (50 ug/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": "bec14279-d399-4bc5-8f6c-e397d6532ba5", "openfda": {"unii": ["MUN5LYG46H"], "rxcui": ["1735003"], "spl_set_id": ["58dcd3f7-e3d8-4929-a186-8f680a51ff11"], "manufacturer_name": ["Phlow Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (81565-205-02)  / 2 mL in 1 VIAL (81565-205-01)", "package_ndc": "81565-205-02", "marketing_end_date": "20280630", "marketing_start_date": "20230111"}], "brand_name": "Fentanyl Citrate", "product_id": "81565-205_bec14279-d399-4bc5-8f6c-e397d6532ba5", "dosage_form": "INJECTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "81565-205", "dea_schedule": "CII", "generic_name": "Fentanyl Citrate", "labeler_name": "Phlow Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fentanyl Citrate", "active_ingredients": [{"name": "FENTANYL CITRATE", "strength": "50 ug/mL"}], "application_number": "NDA019101", "marketing_category": "NDA", "marketing_end_date": "20280630", "marketing_start_date": "20230111"}