NDC 0409-2053

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 Hospira, Inc.. The primary component is Ketamine Hydrochloride.

Product ID0409-2053_0e6f74ee-8e0b-4d98-b5df-1200cc3fa768
NDC0409-2053
Product TypeHuman Prescription Drug
Proprietary NameKetamine Hydrochloride
Generic NameKetamine Hydrochloride
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2004-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA074549
Labeler NameHospira, Inc.
Substance NameKETAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesGeneral Anesthesia [PE],General Anesthetic [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0409-2053-10

10 VIAL, MULTI-DOSE in 1 BOX (0409-2053-10) > 10 mL in 1 VIAL, MULTI-DOSE (0409-2053-20)
Marketing Start Date2004-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-2053-10 [00409205310]

Ketamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA074549
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-11-30

NDC 0409-2053-20 [00409205320]

Ketamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA074549
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-28

Drug Details

Active Ingredients

IngredientStrength
KETAMINE HYDROCHLORIDE50 mg/mL

OpenFDA Data

SPL SET ID:bb912318-2e22-4469-b0a2-774803ee1bb8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238083
  • 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
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