NDC 0362-1095

Lignospan Standard

Lidocaine Hydrochloride And Epinephrine

Lignospan Standard is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Septodont, Inc.. The primary component is Lidocaine Hydrochloride; Epinephrine Bitartrate.

• Product ID: 0362-1095_20c80fcb-d895-405d-844f-414e9d903bfc
• NDC: 0362-1095
• Product Type: Human Prescription Drug
• Proprietary Name: Lignospan Standard
• Generic Name: Lidocaine Hydrochloride And Epinephrine
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-11-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA088390
• Labeler Name: Septodont, Inc.
• Substance Name: LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
• Active Ingredient Strength: 20 mg/mL; mg/mL
• Pharm Classes: Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],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 0362-1095-60

5 BLISTER PACK in 1 CARTON (0362-1095-60) > 10 CARTRIDGE in 1 BLISTER PACK > 1.7 mL in 1 CARTRIDGE

• Marketing Start Date: 2017-11-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0362-1095-60 [00362109560]

Lignospan Standard INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA088390
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-11-28

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	20 mg/mL

OpenFDA Data

• SPL SET ID: f902d2b4-28fc-41b1-a9f7-0d1a63c598aa
• Manufacturer:
  • Septodont, Inc.
• UNII:
  • 30Q7KI53AK
  • V13007Z41A
• RxNorm Concept Unique ID - RxCUI:
  • 1293648
  • 1011809

Pharmacological Class

• Amide Local Anesthetic [EPC]
• Amides [CS]
• Antiarrhythmic [EPC]
• Local Anesthesia [PE]
• Adrenergic alpha-Agonists [MoA]
• Adrenergic beta-Agonists [MoA]
• alpha-Adrenergic Agonist [EPC]
• beta-Adrenergic Agonist [EPC]
• Catecholamine [EPC]
• Catecholamines [CS]
• Amide Local Anesthetic [EPC]
• Amides [CS]
• Antiarrhythmic [EPC]
• Local Anesthesia [PE]
• Adrenergic alpha-Agonists [MoA]
• Adrenergic beta-Agonists [MoA]
• alpha-Adrenergic Agonist [EPC]
• beta-Adrenergic Agonist [EPC]
• Catecholamine [EPC]
• Catecholamines [CS]

NDC Crossover Matching brand name "Lignospan Standard" or generic name "Lidocaine Hydrochloride And Epinephrine"

NDC	Brand Name	Generic Name
0362-1095	Lignospan Standard	Lidocaine Hydrochloride and Epinephrine
51004-1095	Lignospan Standard	Lignospan Standard
0362-0262	Lidocaine	Lidocaine Hydrochloride and Epinephrine
0362-0898	Lidocaine	Lidocaine Hydrochloride and Epinephrine
0404-9886	Lidocaine Hydrochloride and Epinephrine	Lidocaine Hydrochloride and Epinephrine
0404-9891	Lidocaine Hydrochloride and Epinephrine	Lidocaine Hydrochloride and Epinephrine
0404-9896	Lidocaine Hydrochloride and Epinephrine	Lidocaine Hydrochloride and Epinephrine
0409-1209	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE
0409-3177	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE
0409-3178	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE
0362-1096	Lignospan Forte	Lidocaine Hydrochloride and Epinephrine
0404-9972	Xylocaine	Lidocaine Hydrochloride and epinephrine
0404-9976	Xylocaine	Lidocaine Hydrochloride and epinephrine
0404-9977	Xylocaine	Lidocaine Hydrochloride and Epinephrine