NDC 0299-6100

PLIAGLIS

Lidocaine And Tetracaine

PLIAGLIS is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Galderma Laboratories, L.p.. The primary component is Lidocaine; Tetracaine.

Product ID0299-6100_20237304-10de-4a50-92d9-c073c14a6568
NDC0299-6100
Product TypeHuman Prescription Drug
Proprietary NamePLIAGLIS
Generic NameLidocaine And Tetracaine
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2006-06-29
Marketing CategoryNDA / NDA
Application NumberNDA021717
Labeler NameGalderma Laboratories, L.P.
Substance NameLIDOCAINE; TETRACAINE
Active Ingredient Strength70 mg/g; mg/g
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0299-6100-10

1 TUBE in 1 CARTON (0299-6100-10) > 100 g in 1 TUBE
Marketing Start Date2006-06-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0299-6100-60 [00299610060]

PLIAGLIS CREAM
Marketing CategoryNDA
Application NumberNDA021717
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-06-29
Marketing End Date2017-05-03

NDC 0299-6100-35 [00299610035]

PLIAGLIS CREAM
Marketing CategoryNDA
Application NumberNDA021717
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2006-06-29
Marketing End Date2017-05-03

NDC 0299-6100-00 [00299610000]

PLIAGLIS CREAM
Marketing CategoryNDA
Application NumberNDA021717
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-15
Marketing End Date2013-12-02

NDC 0299-6100-10 [00299610010]

PLIAGLIS CREAM
Marketing CategoryNDA
Application NumberNDA021717
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2006-06-29
Marketing End Date2017-05-03

NDC 0299-6100-30 [00299610030]

PLIAGLIS CREAM
Marketing CategoryNDA
Application NumberNDA021717
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-06-29
Marketing End Date2017-05-03

Drug Details

Active Ingredients

IngredientStrength
LIDOCAINE70 mg/g

OpenFDA Data

SPL SET ID:a80355e6-c235-4770-a2cd-240486874eaf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 728126
  • 687443
  • UPC Code
  • 0302996100109
  • Pharmacological Class

    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Antiarrhythmic [EPC]
    • Local Anesthesia [PE]
    • Esters [CS]
    • Local Anesthesia [PE]
    • Ester Local Anesthetic [EPC]

    NDC Crossover Matching brand name "PLIAGLIS" or generic name "Lidocaine And Tetracaine"

    NDCBrand NameGeneric Name
    0299-6100PLIAGLISlidocaine and tetracaine
    51672-5305PLIAGLISLidocaine and Tetracaine
    73575-009Pliaglislidocaine and tetracaine
    73575-010Pliaglislidocaine and tetracaine
    69420-3077LIDOCAINE AND TETRACAINELIDOCAINE AND TETRACAINE
    71800-631Lidocaine and TetracaineLidocaine and Tetracaine
    10885-002Syneralidocaine and tetracaine

    Trademark Results [PLIAGLIS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PLIAGLIS
    PLIAGLIS
    78950628 3413447 Live/Registered
    CRESCITA THERAPEUTICS INC.
    2006-08-11

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