NDC 66312-580

Citanest Forte DENTAL

Prilocaine Hcl And Epinephrine

Citanest Forte DENTAL is a Parenteral 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 ID: 66312-580_2f38d085-6e60-4d25-98f4-96a05e38050a
• NDC: 66312-580
• Product Type: Human Prescription Drug
• Proprietary Name: Citanest Forte DENTAL
• Generic Name: Prilocaine Hcl And Epinephrine
• Dosage Form: Injection, Solution
• Route of Administration: PARENTERAL
• Marketing Start Date: 2017-12-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078959
• Labeler Name: Dentsply Pharmaceutical Inc.
• Substance Name: PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
• Active Ingredient Strength: 40 mg/mL; mg/mL
• Pharm Classes: 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 66312-580-16

50 CARTRIDGE in 1 CARTON (66312-580-16) > 1.8 mL in 1 CARTRIDGE

• Marketing Start Date: 2017-12-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66312-580-16 [66312058016]

Citanest Forte DENTAL INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078959
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-04

Drug Details

Active Ingredients

Ingredient	Strength
PRILOCAINE HYDROCHLORIDE	40 mg/mL

OpenFDA Data

• SPL SET ID: 60c8710b-ae55-4fdf-e053-2991aa0adc75
• Manufacturer:
  • Dentsply Pharmaceutical Inc.
• UNII:
  • MJW015BAPH
  • 30Q7KI53AK
• RxNorm Concept Unique ID - RxCUI:
  • 1596950
  • 1993224

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]