fentanyl citrate

Generic: fentanyl citrate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fentanyl citrate
Generic Name fentanyl citrate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

fentanyl citrate 50 ug/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6289
Product ID 0641-6289_133a8135-0c15-44cc-86c1-5acb6819fc1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019101
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2025-08-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416289
Hyphenated Format 0641-6289

Supplemental Identifiers

RxCUI
1735003 1735008
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 (0641-6289-25) / 2 mL in 1 VIAL (0641-6289-01)
source: ndc

Packages (1)

0641-6289-25 25 VIAL in 1 CARTON (0641-6289-25) / 2 mL in 1 VIAL (0641-6289-01)

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": "133a8135-0c15-44cc-86c1-5acb6819fc1a", "openfda": {"unii": ["MUN5LYG46H"], "rxcui": ["1735003", "1735008"], "spl_set_id": ["c5fcdcbd-1dd1-4ebf-aa0d-edfe845414b7"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-6289-25)  / 2 mL in 1 VIAL (0641-6289-01)", "package_ndc": "0641-6289-25", "marketing_start_date": "20250829"}], "brand_name": "Fentanyl Citrate", "product_id": "0641-6289_133a8135-0c15-44cc-86c1-5acb6819fc1a", "dosage_form": "INJECTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0641-6289", "dea_schedule": "CII", "generic_name": "Fentanyl Citrate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "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_start_date": "20250829", "listing_expiration_date": "20271231"}