NDC 0362-9014

Prilocaine Hydrochloride

Prilocaine Hydrochloride

Prilocaine Hydrochloride 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.

• Product ID: 0362-9014_30b93d20-538b-4c99-8412-24a76b7a6e20
• NDC: 0362-9014
• Product Type: Human Prescription Drug
• Proprietary Name: Prilocaine Hydrochloride
• Generic Name: Prilocaine Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2011-01-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA079235
• Labeler Name: Septodont 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: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 0362-9014-50

50 CARTRIDGE in 1 CARTON (0362-9014-50) > 1.8 mL in 1 CARTRIDGE

• Marketing Start Date: 2011-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0362-9014-50 [00362901450]

Prilocaine Hydrochloride INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA079235
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-01-01
• Inactivation Date: 2019-10-29

Drug Details

Active Ingredients

Ingredient	Strength
PRILOCAINE HYDROCHLORIDE	40 mg/mL

OpenFDA Data

• SPL SET ID: ca454f96-2e2d-46ed-95af-c741726773de
• Manufacturer:
  • Septodont Inc.
• UNII:
  • MJW015BAPH
• RxNorm Concept Unique ID - RxCUI:
  • 1595048

Pharmacological Class

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

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

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