NDC 0362-9010

Octocaine 50

Lidocaine Hydrochloride And Epinephrine Bitartrate

Octocaine 50 is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Septodont. The primary component is Lidocaine Hydrochloride; Epinephrine Bitartrate.

• Product ID: 0362-9010_63b67155-b87d-4f75-b661-8a91b8284c26
• NDC: 0362-9010
• Product Type: Human Prescription Drug
• Proprietary Name: Octocaine 50
• Generic Name: Lidocaine Hydrochloride And Epinephrine Bitartrate
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2011-11-07
• Marketing Category: ANDA / ANDA
• Application Number: ANDA088389
• Labeler Name: Septodont
• 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: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 0362-9010-05

50 CARTRIDGE in 1 CARTON (0362-9010-05) > 1.7 mL in 1 CARTRIDGE

• Marketing Start Date: 2011-11-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0362-9010-05 [00362901005]

Octocaine 50 INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA088389
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-11-07
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	20 mg/mL

OpenFDA Data

• SPL SET ID: 7dfc8c0e-3d4d-4142-8e99-df833702cb9b
• Manufacturer:
  • Septodont
• UNII:
  • 30Q7KI53AK
  • V13007Z41A
• RxNorm Concept Unique ID - RxCUI:
  • 1657026
  • 1011825

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]

NDC Crossover Matching brand name "Octocaine 50" or generic name "Lidocaine Hydrochloride And Epinephrine Bitartrate"

NDC	Brand Name	Generic Name
0362-9010	Octocaine 50	Lidocaine Hydrochloride and Epinephrine Bitartrate
0404-6500	LIDOCAINE	Lidocaine Hydrochloride and Epinephrine Bitartrate
0404-6512	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate
31382-262	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate
31382-898	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate
43128-105	LIDOCAINE	Lidocaine Hydrochloride and Epinephrine Bitartrate
50227-1020	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate
50227-1030	LIDOCAINE	Lidocaine Hydrochloride and Epinephrine Bitartrate
51004-0550	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate
51004-1051	LIDOCAINE	Lidocaine Hydrochloride and Epinephrine Bitartrate
66467-9710	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate
66467-9730	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate
66975-415	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate
66975-425	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate
67239-0240	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate
71347-210	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate
43305-1030	LIDOCAINE HCl	Lidocaine Hydrochloride and Epinephrine Bitartrate
42756-1030	Lidocaine Hydrochloride and Epinephrine Bitartrate	Lidocaine Hydrochloride and Epinephrine Bitartrate
51004-2010	Lidocaine Hydrochloride and Epinephrine Bitartrate	Lidocaine Hydrochloride and Epinephrine Bitartrate
51004-1096	Lignospan Forte	Lidocaine Hydrochloride and Epinephrine Bitartrate
51004-1095	Lignospan Standard	Lidocaine Hydrochloride and Epinephrine Bitartrate
0362-9023	Octocaine 100	Lidocaine Hydrochloride and Epinephrine Bitartrate
66312-176	Xylocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate
66312-181	Xylocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate