NDC 67457-001

Ketamine Hydrochloride

Ketamine Hydrochloride

Ketamine Hydrochloride is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Ketamine Hydrochloride.

Product ID67457-001_16097739-c57b-444e-bc23-8441c1714687
NDC67457-001
Product TypeHuman Prescription Drug
Proprietary NameKetamine Hydrochloride
Generic NameKetamine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2013-06-04
Marketing CategoryANDA / ANDA
Application NumberANDA076092
Labeler NameMylan Institutional LLC
Substance NameKETAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesGeneral Anesthesia [PE],General Anesthetic [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 67457-001-10

10 VIAL in 1 CARTON (67457-001-10) > 10 mL in 1 VIAL (67457-001-00)
Marketing Start Date2013-06-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-001-00 [67457000100]

Ketamine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076092
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-06-04

NDC 67457-001-10 [67457000110]

Ketamine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076092
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-06-04

Drug Details

Active Ingredients

IngredientStrength
KETAMINE HYDROCHLORIDE50 mg/mL

OpenFDA Data

SPL SET ID:505dc937-694d-4a3a-befa-aae20071b4c7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238083
  • 238082
  • 238084

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.