NDC 52584-108

KETAMINE HYDROCHLORIDE

Ketamine Hydrochloride

KETAMINE HYDROCHLORIDE is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Ketamine Hydrochloride.

Product ID52584-108_215f1cd6-5867-4ac9-9751-4bbf23e5e881
NDC52584-108
Product TypeHuman Prescription Drug
Proprietary NameKETAMINE HYDROCHLORIDE
Generic NameKetamine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA076092
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NameKETAMINE HYDROCHLORIDE
Active Ingredient Strength100 mg/mL
Pharm ClassesGeneral Anesthesia [PE],General Anesthetic [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52584-108-00

1 VIAL, MULTI-DOSE in 1 BAG (52584-108-00) > 10 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2018-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-108-00 [52584010800]

KETAMINE HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076092
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-28

Drug Details

Active Ingredients

IngredientStrength
KETAMINE HYDROCHLORIDE100 mg/mL

OpenFDA Data

SPL SET ID:a9f60fc5-1d87-4264-b1a6-4d6722f86e08
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238083

    • Pharmacological Class

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

    NDC Crossover Matching brand name "KETAMINE HYDROCHLORIDE" or generic name "Ketamine Hydrochloride"

    NDCBrand NameGeneric Name
    0143-9508Ketamine HydrochlorideKetamine Hydrochloride
    0143-9509Ketamine HydrochlorideKetamine Hydrochloride
    0404-9881KETAMINE HYDROCHLORIDEketamine hydrochloride
    0404-9882KETAMINE HYDROCHLORIDEketamine hydrochloride
    0409-0040Ketamine HydrochlorideKETAMINE HYDROCHLORIDE
    0409-2051Ketamine HydrochlorideKETAMINE HYDROCHLORIDE
    0409-2053Ketamine HydrochlorideKETAMINE HYDROCHLORIDE
    52584-038KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDE
    52584-040KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDE
    52584-108KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDE
    67457-001Ketamine HydrochlorideKetamine Hydrochloride
    67457-181Ketamine HydrochlorideKetamine Hydrochloride
    67457-108Ketamine HydrochlorideKetamine Hydrochloride
    72572-321Ketamine HydrochlorideKetamine Hydrochloride
    72572-320Ketamine HydrochlorideKetamine Hydrochloride
    70518-2787Ketamine HydrochlorideKetamine Hydrochloride
    0404-9880KETALARketamine hydrochloride
    42023-113Ketalarketamine hydrochloride
    42023-114Ketalarketamine hydrochloride
    42023-115Ketalarketamine hydrochloride
    52584-037KETALARketamine hydrochloride
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