NDC 43305-1080

Pearson Mepivacaine

Mepivacaine Hydrochloride

Pearson Mepivacaine is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Pearson Dental. The primary component is Mepivacaine Hydrochloride.

Product ID43305-1080_1b5564d3-ab36-40c8-b3be-81e747929fc3
NDC43305-1080
Product TypeHuman Prescription Drug
Proprietary NamePearson Mepivacaine
Generic NameMepivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2012-05-15
Marketing CategoryANDA / ANDA
Application NumberANDA088387
Labeler NamePearson Dental
Substance NameMEPIVACAINE HYDROCHLORIDE
Active Ingredient Strength30 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 43305-1080-5

50 CARTRIDGE in 1 CARTON (43305-1080-5) > 1.7 mL in 1 CARTRIDGE
Marketing Start Date2012-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43305-1080-5 [43305108005]

Pearson Mepivacaine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA088387
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-05-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MEPIVACAINE HYDROCHLORIDE30 mg/mL

OpenFDA Data

SPL SET ID:d303afcf-73b3-4dbf-88c9-0ae20f0d879a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1305263
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Pearson Mepivacaine" or generic name "Mepivacaine Hydrochloride"

    NDCBrand NameGeneric Name
    43305-1080Pearson MepivacaineMepivacaine 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
    50090-4408PolocaineMEPIVACAINE HYDROCHLORIDE
    50090-4517PolocaineMEPIVACAINE HYDROCHLORIDE
    0362-1098Scandonest 3% PlainMepivacaine Hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.