NDC 0362-1098

Scandonest 3% Plain

Mepivacaine Hydrochloride

Scandonest 3% Plain is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Septodont, Inc.. The primary component is Mepivacaine Hydrochloride.

Product ID0362-1098_2a4b700f-3dbc-4457-a346-274ce169db8b
NDC0362-1098
Product TypeHuman Prescription Drug
Proprietary NameScandonest 3% Plain
Generic NameMepivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2017-12-22
Marketing CategoryANDA / ANDA
Application NumberANDA088387
Labeler NameSeptodont, Inc.
Substance NameMEPIVACAINE HYDROCHLORIDE
Active Ingredient Strength30 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0362-1098-90

5 BLISTER PACK in 1 CARTON (0362-1098-90) > 10 CARTRIDGE in 1 BLISTER PACK > 1.7 mL in 1 CARTRIDGE
Marketing Start Date2017-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0362-1098-90 [00362109890]

Scandonest 3% Plain INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA088387
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-22

Drug Details

Active Ingredients

IngredientStrength
MEPIVACAINE HYDROCHLORIDE30 mg/mL

OpenFDA Data

SPL SET ID:af6ff5f6-7221-421b-9b7c-8fcee4a47772
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1012762
  • 1305263

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Scandonest 3% Plain" or generic name "Mepivacaine Hydrochloride"

    NDCBrand NameGeneric Name
    0362-1098Scandonest 3% PlainMepivacaine Hydrochloride
    0362-0753CarbocaineMepivacaine Hydrochloride
    0409-1036CarbocaineMepivacaine Hydrochloride
    0409-1038CarbocaineMepivacaine Hydrochloride
    0409-1041CarbocaineMepivacaine Hydrochloride
    0409-1067CarbocaineMepivacaine Hydrochloride
    0409-2047CarbocaineMepivacaine Hydrochloride
    31382-753CarbocaineMepivacaine hydrochloride
    42756-1080IQ Dental MepivacaineMepivacaine Hydrochloride
    43128-005MepivacaineMepivacaine Hydrochloride
    50227-1080MepivacaineMepivacaine Hydrochloride
    0404-6730Mepivacaine HydrochlorideMepivacaine Hydrochloride
    43305-1080Pearson MepivacaineMepivacaine Hydrochloride
    50090-4408PolocaineMEPIVACAINE HYDROCHLORIDE
    50090-4517PolocaineMEPIVACAINE HYDROCHLORIDE
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