remifentanil hydrochloride

Generic: remifentanil hydrochloride

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

Drug Facts

Product Profile

Brand Name remifentanil hydrochloride
Generic Name remifentanil hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

remifentanil hydrochloride 1 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-724
Product ID 63323-724_2f27e51f-2b55-47ee-bd4a-001b71c60622
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206223
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2018-01-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323724
Hyphenated Format 63323-724

Supplemental Identifiers

RxCUI
1729578 1729584 1729710
UPC
0363323725013 0363323724016 0363323723019
UNII
5V444H5WIC

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 remifentanil hydrochloride (source: ndc)
Generic Name remifentanil hydrochloride (source: ndc)
Application Number ANDA206223 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-724-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-724-01)
source: ndc

Packages (1)

63323-724-05 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-724-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-724-01)

Ingredients (1)

remifentanil hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Remifentanil Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2f27e51f-2b55-47ee-bd4a-001b71c60622", "openfda": {"upc": ["0363323725013", "0363323724016", "0363323723019"], "unii": ["5V444H5WIC"], "rxcui": ["1729578", "1729584", "1729710"], "spl_set_id": ["d2374b84-81c9-44f9-a4a9-1071281b2531"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-724-05)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-724-01)", "package_ndc": "63323-724-05", "marketing_start_date": "20180119"}], "brand_name": "Remifentanil Hydrochloride", "product_id": "63323-724_2f27e51f-2b55-47ee-bd4a-001b71c60622", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63323-724", "dea_schedule": "CII", "generic_name": "Remifentanil Hydrochloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Remifentanil Hydrochloride", "active_ingredients": [{"name": "REMIFENTANIL HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA206223", "marketing_category": "ANDA", "marketing_start_date": "20180119", "listing_expiration_date": "20261231"}