NDC 52584-040

KETAMINE HYDROCHLORIDE

Ketamine Hydrochloride

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

Product ID52584-040_1a6c45fe-c994-48a7-b4e9-b8051e5bc05e
NDC52584-040
Product TypeHuman Prescription Drug
Proprietary NameKETAMINE HYDROCHLORIDE
Generic NameKetamine Hydrochloride
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2012-10-16
Marketing CategoryANDA / ANDA
Application NumberANDA074549
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameKETAMINE HYDROCHLORIDE
Active Ingredient Strength100 mg/mL
Pharm ClassesGeneral Anesthesia [PE],General Anesthetic [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 52584-040-05

1 VIAL, MULTI-DOSE in 1 BAG (52584-040-05) > 5 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2012-10-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-040-05 [52584004005]

KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA074549
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-10-16

Drug Details

Active Ingredients

IngredientStrength
KETAMINE HYDROCHLORIDE100 mg/mL

OpenFDA Data

SPL SET ID:6faea7c1-7f67-4181-9e74-54175e315612
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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