NDC 63323-475

Nesacaine

Chloroprocaine Hydrochloride

Nesacaine is a Infiltration; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Chloroprocaine Hydrochloride.

Product ID63323-475_46570679-3557-4250-bb21-b406097e106d
NDC63323-475
Product TypeHuman Prescription Drug
Proprietary NameNesacaine
Generic NameChloroprocaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINFILTRATION; PERINEURAL
Marketing Start Date2010-10-14
Marketing CategoryNDA / NDA
Application NumberNDA009435
Labeler NameFresenius Kabi USA, LLC
Substance NameCHLOROPROCAINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesEster Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63323-475-37

25 VIAL, MULTI-DOSE in 1 TRAY (63323-475-37) > 30 mL in 1 VIAL, MULTI-DOSE (63323-475-01)
Marketing Start Date2010-10-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-475-37 [63323047537]

Nesacaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA009435
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-10-14

NDC 63323-475-01 [63323047501]

Nesacaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA009435
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-03

NDC 63323-475-30 [63323047530]

Nesacaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA009435
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-14
Marketing End Date2011-09-28

Drug Details

Active Ingredients

IngredientStrength
CHLOROPROCAINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:a844e68a-1462-40e4-be5e-f56214906eb9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1794186
  • 1794184
  • 992811
  • 992803
  • 992801
  • 992807
  • 992805
  • 992809
    • UPC Code
  • 0363323478278
  • 0363323475376
  • 0363323476373

    • Pharmacological Class

    • Ester Local Anesthetic [EPC]
    • Esters [CS]
    • Local Anesthesia [PE]

    NDC Crossover Matching brand name "Nesacaine" or generic name "Chloroprocaine Hydrochloride"

    NDCBrand NameGeneric Name
    0404-9926NesacaineChloroprocaine Hydrochloride
    0404-9927NESACAINEchloroprocaine hydrochloride
    52584-475NesacaineChloroprocaine Hydrochloride
    52584-476NESACAINEchloroprocaine hydrochloride
    63323-475NesacaineCHLOROPROCAINE HYDROCHLORIDE
    63323-476NesacaineCHLOROPROCAINE HYDROCHLORIDE
    63323-477NesacaineCHLOROPROCAINE HYDROCHLORIDE
    63323-478NesacaineCHLOROPROCAINE HYDROCHLORIDE
    0143-9209Chloroprocaine HydrochlorideChloroprocaine Hydrochloride
    0143-9210Chloroprocaine HydrochlorideChloroprocaine Hydrochloride
    0264-7055ClorotekalCHLOROPROCAINE HYDROCHLORIDE

    Trademark Results [Nesacaine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NESACAINE
    NESACAINE
    72018377 0648536 Live/Registered
    WALLACE & TIERNAN INCORPORATED
    1956-10-29
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