NDC 63323-723

Remifentanil Hydrochloride

Remifentanil Hydrochloride

Remifentanil Hydrochloride is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Remifentanil Hydrochloride.

Product ID63323-723_1976a804-bfb7-4ea7-b89a-1d7b521b37ec
NDC63323-723
Product TypeHuman Prescription Drug
Proprietary NameRemifentanil Hydrochloride
Generic NameRemifentanil Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-01-19
Marketing CategoryANDA / ANDA
Application NumberANDA206223
Labeler NameFresenius Kabi USA, LLC
Substance NameREMIFENTANIL HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63323-723-03

10 VIAL, SINGLE-DOSE in 1 CARTON (63323-723-03) > 3 mL in 1 VIAL, SINGLE-DOSE (63323-723-01)
Marketing Start Date2018-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-723-04 [63323072304]

Remifentanil Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA206223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-19

NDC 63323-723-01 [63323072301]

Remifentanil Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA206223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-19

NDC 63323-723-03 [63323072303]

Remifentanil Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA206223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-19

NDC 63323-723-06 [63323072306]

Remifentanil Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA206223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-19

Drug Details

Active Ingredients

IngredientStrength
REMIFENTANIL HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:d2374b84-81c9-44f9-a4a9-1071281b2531
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1729710
  • 1729578
  • 1729584

    • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "Remifentanil Hydrochloride" or generic name "Remifentanil Hydrochloride"

    NDCBrand NameGeneric Name
    0143-9391REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDE
    0143-9392REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDE
    0143-9393REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDE
    63323-723Remifentanil HydrochlorideRemifentanil Hydrochloride
    63323-724Remifentanil HydrochlorideRemifentanil Hydrochloride
    63323-725Remifentanil HydrochlorideRemifentanil Hydrochloride
    68475-505REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDE
    68475-506REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDE
    68475-507REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDE
    67457-198UltivaRemifentanil Hydrochloride
    67457-912UltivaRemifentanil Hydrochloride
    67457-913UltivaRemifentanil Hydrochloride
    67457-914UltivaRemifentanil Hydrochloride
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