NDC 52584-695

Amidate

Etomidate

Amidate is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Etomidate.

Product ID52584-695_19b94bdf-efaf-47bf-8965-925b706e0051
NDC52584-695
Product TypeHuman Prescription Drug
Proprietary NameAmidate
Generic NameEtomidate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-08-01
Marketing CategoryNDA / NDA
Application NumberNDA018227
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameETOMIDATE
Active Ingredient Strength2 mg/mL
Pharm ClassesGeneral Anesthesia [PE],General Anesthetic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-695-01

1 VIAL, SINGLE-DOSE in 1 BAG (52584-695-01) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-695-01 [52584069501]

Amidate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018227
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-23

Drug Details

Active Ingredients

IngredientStrength
ETOMIDATE2 mg/mL

OpenFDA Data

SPL SET ID:90744801-0358-4193-8c3e-46abb2f5d7e8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1654009
  • 1654006
  • Pharmacological Class

    • General Anesthesia [PE]
    • General Anesthetic [EPC]

    NDC Crossover Matching brand name "Amidate" or generic name "Etomidate"

    NDCBrand NameGeneric Name
    0404-9811AmidateEtomidate
    0409-6695AmidateETOMIDATE
    0409-8060AmidateEtomidate
    52584-695AmidateEtomidate
    0143-9310EtomidateEtomidate
    0143-9311EtomidateEtomidate
    0143-9506EtomidateEtomidate
    0143-9507EtomidateEtomidate
    23155-160EtomidateEtomidate
    23155-522EtomidateEtomidate
    25021-674etomidateetomidate
    51662-1485ETOMIDATEETOMIDATE
    51662-1542ETOMIDATEETOMIDATE
    55150-221ETOMIDATEETOMIDATE
    55150-222ETOMIDATEETOMIDATE
    65145-127EtomidateEtomidate
    65145-128EtomidateEtomidate
    65219-445EtomidateEtomidate
    65219-447EtomidateEtomidate
    65841-818etomidateetomidate
    67457-902EtomidateEtomidate
    67457-903EtomidateEtomidate
    68382-545etomidateetomidate
    70518-1003Etomidateetomidate

    Trademark Results [Amidate]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AMIDATE
    AMIDATE
    77668975 3663648 Live/Registered
    Hospira, Inc.
    2009-02-12
    AMIDATE
    AMIDATE
    73119674 1078739 Dead/Expired
    ABBOTT LABORATORIES
    1977-03-21

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