NDC 63323-283

Polocaine

Mepivacaine Hydrochloride

Polocaine is a Infiltration Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Mepivacaine Hydrochloride.

Product ID63323-283_8fed7b18-6eb5-3397-e053-2995a90ad9f8
NDC63323-283
Product TypeHuman Prescription Drug
Proprietary NamePolocaine
Generic NameMepivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINFILTRATION
Marketing Start Date2009-07-20
Marketing CategoryANDA / ANDA
Application NumberANDA089407
Labeler NameFresenius Kabi USA, LLC
Substance NameMEPIVACAINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63323-283-57

25 VIAL, MULTI-DOSE in 1 TRAY (63323-283-57) > 50 mL in 1 VIAL, MULTI-DOSE (63323-283-01)
Marketing Start Date2009-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-283-01 [63323028301]

Polocaine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089407
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-12

NDC 63323-283-50 [63323028350]

Polocaine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089407
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-07-20
Marketing End Date2018-02-27

NDC 63323-283-57 [63323028357]

Polocaine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089407
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-07-20

Drug Details

Active Ingredients

IngredientStrength
MEPIVACAINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:a27d0815-ae6b-4a21-a8f5-564c01e83814
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1866503
  • 1012741
  • 1866515
  • 1866524
  • 1866531
  • 1012722
  • 1012737
  • 1012735
  • 1012726
  • 1012731
    • UPC Code
  • 0363323294274
  • 0363323283575

    • 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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