NDC 0362-9014

Prilocaine Hydrochloride

Prilocaine Hydrochloride

Prilocaine Hydrochloride is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Septodont Inc.. The primary component is Prilocaine Hydrochloride.

Product ID0362-9014_30b93d20-538b-4c99-8412-24a76b7a6e20
NDC0362-9014
Product TypeHuman Prescription Drug
Proprietary NamePrilocaine Hydrochloride
Generic NamePrilocaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2011-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA079235
Labeler NameSeptodont Inc.
Substance NamePRILOCAINE HYDROCHLORIDE
Active Ingredient Strength40 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0362-9014-50

50 CARTRIDGE in 1 CARTON (0362-9014-50) > 1.8 mL in 1 CARTRIDGE
Marketing Start Date2011-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0362-9014-50 [00362901450]

Prilocaine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA079235
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-01
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
PRILOCAINE HYDROCHLORIDE40 mg/mL

OpenFDA Data

SPL SET ID:ca454f96-2e2d-46ed-95af-c741726773de
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1595048
  • Pharmacological Class

    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Local Anesthesia [PE]

    NDC Crossover Matching brand name "Prilocaine Hydrochloride" or generic name "Prilocaine Hydrochloride"

    NDCBrand NameGeneric Name
    0362-9014Prilocaine Hydrochlorideprilocaine hydrochloride
    66312-630Citanest Plainprilocaine hydrochloride

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