NDC 0362-9013

Prilocaine Hydrochloride with Epinephrine

Prilocaine And Epinephrine

Prilocaine Hydrochloride with Epinephrine is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Septodont Inc.. The primary component is Prilocaine Hydrochloride; Epinephrine Bitartrate.

Product ID0362-9013_e470f75b-5f30-47a1-886c-be1768920f8f
NDC0362-9013
Product TypeHuman Prescription Drug
Proprietary NamePrilocaine Hydrochloride with Epinephrine
Generic NamePrilocaine And Epinephrine
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2011-09-10
Marketing CategoryANDA / ANDA
Application NumberANDA078959
Labeler NameSeptodont Inc.
Substance NamePRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active Ingredient Strength40 mg/mL; mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0362-9013-50

50 CARTRIDGE in 1 CARTON (0362-9013-50) > 1.8 mL in 1 CARTRIDGE
Marketing Start Date2011-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0362-9013-50 [00362901350]

Prilocaine Hydrochloride with Epinephrine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078959
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-09-10
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
PRILOCAINE HYDROCHLORIDE40 mg/mL

OpenFDA Data

SPL SET ID:b374a5f1-ef37-402d-b011-ca8d20689f02
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1596950
  • Pharmacological Class

    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Local Anesthesia [PE]
    • Adrenergic alpha-Agonists [MoA]
    • Adrenergic beta-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]
    • beta-Adrenergic Agonist [EPC]
    • Catecholamine [EPC]
    • Catecholamines [CS]

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