NDC 0264-7055

Clorotekal

Chloroprocaine Hydrochloride

Clorotekal is a Intrathecal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by B. Braun Medical Inc.. The primary component is Chloroprocaine Hydrochloride.

Product ID0264-7055_b13b7fe4-d1d8-4cda-9ac8-098f01530b9e
NDC0264-7055
Product TypeHuman Prescription Drug
Proprietary NameClorotekal
Generic NameChloroprocaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRATHECAL
Marketing Start Date2018-05-01
Marketing CategoryNDA / NDA
Application NumberNDA208791
Labeler NameB. Braun Medical Inc.
Substance NameCHLOROPROCAINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesEster Local Anesthetic [EPC],Esters [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0264-7055-10

10 AMPULE in 1 CARTON (0264-7055-10) > 5 mL in 1 AMPULE (0264-7055-05)
Marketing Start Date2018-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0264-7055-10 [00264705510]

Clorotekal INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208791
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-01

NDC 0264-7055-05 [00264705505]

Clorotekal INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208791
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-01

Drug Details

Active Ingredients

IngredientStrength
CHLOROPROCAINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:90f7a095-f6db-456b-951f-9aee54c5dbc0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1946735
  • 1946730

    • Pharmacological Class

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

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

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

    Trademark Results [Clorotekal]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CLOROTEKAL
    CLOROTEKAL
    79127330 4499961 Live/Registered
    Sintetica SA
    2013-01-23
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