NDC 66312-441

Polocaine

Mepivacaine Hydrochloride

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

Product ID66312-441_1dd09e2e-67de-4b76-a024-ffd02b62ea00
NDC66312-441
Product TypeHuman Prescription Drug
Proprietary NamePolocaine
Generic NameMepivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1984-10-10
Marketing CategoryANDA / ANDA
Application NumberANDA088387
Labeler NameDentsply Pharmaceutical
Substance NameMEPIVACAINE HYDROCHLORIDE
Active Ingredient Strength30 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 66312-441-16

50 CARTRIDGE in 1 CARTON (66312-441-16) > 1.7 mL in 1 CARTRIDGE
Marketing Start Date1984-10-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66312-441-16 [66312044116]

Polocaine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA088387
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1984-10-10

Drug Details

Active Ingredients

IngredientStrength
MEPIVACAINE HYDROCHLORIDE30 mg/mL

OpenFDA Data

SPL SET ID:25074a6a-7f67-4ad8-86e0-2afe23ec5d04
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1012756
  • 1305263

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    50090-4408PolocaineMEPIVACAINE HYDROCHLORIDE
    50090-4517PolocaineMEPIVACAINE HYDROCHLORIDE
    63323-283PolocainePolocaine
    63323-296PolocainePolocaine
    66312-441PolocainePolocaine
    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
    0362-1098Scandonest 3% PlainMepivacaine Hydrochloride

    Trademark Results [Polocaine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    POLOCAINE
    POLOCAINE
    73499932 1376828 Live/Registered
    ASTRA PHARMACEUTICAL PRODUCTS, INC.
    1984-09-18
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