NDC 66312-540

Citanest Forte

Prilocaine Hydrochloride And Epinephrine Bitartrate

Citanest Forte is a Submucosal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Dentsply Pharmaceutical Inc.. The primary component is Prilocaine Hydrochloride; Epinephrine Bitartrate.

Product ID66312-540_5bc16e4b-6878-839f-e053-2991aa0abf4a
NDC66312-540
Product TypeHuman Prescription Drug
Proprietary NameCitanest Forte
Generic NamePrilocaine Hydrochloride And Epinephrine Bitartrate
Dosage FormInjection, Solution
Route of AdministrationSUBMUCOSAL
Marketing Start Date1965-11-18
Marketing CategoryNDA / NDA
Application NumberNDA021383
Labeler NameDentsply Pharmaceutical 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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 66312-540-16

50 CARTRIDGE in 1 CARTON (66312-540-16) > 1.7 mL in 1 CARTRIDGE
Marketing Start Date1965-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66312-540-16 [66312054016]

Citanest Forte INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021383
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1965-11-18
Inactivation Date2020-01-31

NDC 66312-540-14 [66312054014]

Citanest Forte INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021383
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1965-11-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PRILOCAINE HYDROCHLORIDE40 mg/mL

OpenFDA Data

SPL SET ID:a654df2a-68bc-43c5-bd97-ad43f8679dc0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1595042
  • 1012709
  • 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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