NDC 0362-1097

Scandonest 2% L

Mepivacaine Hydrochloride And Levonordefrin

Scandonest 2% L is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Septodont, Inc.. The primary component is Levonordefrin; Mepivacaine Hydrochloride.

• Product ID: 0362-1097_49286564-42b5-461b-9671-35ac106165ce
• NDC: 0362-1097
• Product Type: Human Prescription Drug
• Proprietary Name: Scandonest 2% L
• Generic Name: Mepivacaine Hydrochloride And Levonordefrin
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-12-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA088388
• Labeler Name: Septodont, Inc.
• Substance Name: LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE
• Active Ingredient Strength: 0 mg/mL; mg/mL
• Pharm Classes: Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0362-1097-80

5 BLISTER PACK in 1 CARTON (0362-1097-80) > 10 CARTRIDGE in 1 BLISTER PACK > 1.7 mL in 1 CARTRIDGE

• Marketing Start Date: 2017-12-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0362-1097-80 [00362109780]

Scandonest 2% L INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA088388
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-18

Drug Details

Active Ingredients

Ingredient	Strength
MEPIVACAINE HYDROCHLORIDE	20 mg/mL

OpenFDA Data

• SPL SET ID: ec38d293-cf9d-4282-8885-d025c55b13b9
• Manufacturer:
  • Septodont, Inc.
• UNII:
  • 4VFX2L7EM5
  • V008L6478D
• RxNorm Concept Unique ID - RxCUI:
  • 1661504
  • 1012769

Pharmacological Class

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

NDC Crossover Matching brand name "Scandonest 2% L" or generic name "Mepivacaine Hydrochloride And Levonordefrin"

NDC	Brand Name	Generic Name
0362-1097	Scandonest 2% L	Mepivacaine Hydrochloride and Levonordefrin
0362-0931	Carbocaine with Neo-Cobefrin	Mepivacaine Hydrochloride and Levonordefrin
31382-931	Carbocaine with Neo-Cobefrin	Mepivacaine hydrochloride and Levonordefrin
66467-9790	Mepivacaine Hydrochloride and Levonordefrin	Mepivacaine Hydrochloride and Levonordefrin
51004-1097	Scandonest L	Mepivacaine Hydrochloride and Levonordefrin