NDC 66312-630

Citanest Plain

Prilocaine Hydrochloride

Citanest Plain 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.

• Product ID: 66312-630_14eaeca2-d602-48eb-a384-eee02a9a1b04
• NDC: 66312-630
• Product Type: Human Prescription Drug
• Proprietary Name: Citanest Plain
• Generic Name: Prilocaine Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: SUBMUCOSAL
• Marketing Start Date: 1965-11-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA079235
• Labeler Name: Dentsply Pharmaceutical Inc.
• Substance Name: PRILOCAINE HYDROCHLORIDE
• Active Ingredient Strength: 40 mg/mL
• Pharm Classes: Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 66312-630-14

50 CARTRIDGE in 1 CARTON (66312-630-14) > 1.8 mL in 1 CARTRIDGE

• Marketing Start Date: 1965-11-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66312-630-14 [66312063014]

Citanest Plain INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA079235
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1965-11-18

Drug Details

Active Ingredients

Ingredient	Strength
PRILOCAINE HYDROCHLORIDE	40 mg/mL

OpenFDA Data

• SPL SET ID: db23a56f-1e41-4843-9220-1b2e3059db41
• Manufacturer:
  • Dentsply Pharmaceutical Inc.
• UNII:
  • MJW015BAPH
• RxNorm Concept Unique ID - RxCUI:
  • 1012706
  • 1595048

Pharmacological Class

• Amide Local Anesthetic [EPC]
• Amides [CS]
• Local Anesthesia [PE]

NDC Crossover Matching brand name "Citanest Plain" or generic name "Prilocaine Hydrochloride"

NDC	Brand Name	Generic Name
66312-630	Citanest Plain	prilocaine hydrochloride
0362-9014	Prilocaine Hydrochloride	prilocaine hydrochloride