NDC 52584-481

Xylocaine

Lidocaine Hydrochloride, Epinephrine Bitartrate Injection, Solution

Xylocaine is a Infiltration; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Lidocaine Hydrochloride Anhydrous; Epinephrine Bitartrate.

• Product ID: 52584-481_2c415d74-67e4-48ed-97b7-9d685cb45d10
• NDC: 52584-481
• Product Type: Human Prescription Drug
• Proprietary Name: Xylocaine
• Generic Name: Lidocaine Hydrochloride, Epinephrine Bitartrate Injection, Solution
• Dosage Form: Injection, Solution
• Route of Administration: INFILTRATION; PERINEURAL
• Marketing Start Date: 2011-09-28
• Marketing Category: NDA / NDA
• Application Number: NDA006488
• Labeler Name: General Injectables & Vaccines, Inc
• Substance Name: LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
• Active Ingredient Strength: 5 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: 2022-12-31

Packaging

NDC 52584-481-57

1 VIAL in 1 BAG (52584-481-57) > 50 mL in 1 VIAL

• Marketing Start Date: 2011-09-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52584-481-57 [52584048157]

Xylocaine INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA006488
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-09-28

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg/mL

OpenFDA Data

• SPL SET ID: 52146dd3-bbf8-4486-803f-69a779adbcad
• Manufacturer:
  • General Injectables & Vaccines, Inc
• UNII:
  • EC2CNF7XFP
  • 30Q7KI53AK
• RxNorm Concept Unique ID - RxCUI:
  • 1010745
  • 1010749

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 "Xylocaine" or generic name "Lidocaine Hydrochloride, Epinephrine Bitartrate Injection, Solution"

NDC	Brand Name	Generic Name
0404-9972	Xylocaine	Lidocaine Hydrochloride and epinephrine
0404-9973	Xylocaine	Lidocaine Hydrochloride
0404-9974	Xylocaine	Lidocaine HCl
0404-9975	Xylocaine	Lidocaine hydrochloride, epinephrine bitartrate injection, solution
0404-9976	Xylocaine	Lidocaine Hydrochloride and epinephrine
0404-9977	Xylocaine	Lidocaine Hydrochloride and Epinephrine
21695-466	XYLOCAINE	Lidocaine Hydrochloride
50090-3321	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
52584-481	Xylocaine	Lidocaine hydrochloride, epinephrine bitartrate injection, solution
52584-482	Xylocaine	Lidocaine Hydrochloride and Epinephrine
52584-483	Xylocaine	Lidocaine Hydrochloride and epinephrine
52584-484	Xylocaine	Lidocaine Hydrochloride
52584-485	Xylocaine	Lidocaine Hydrochloride
52584-486	Xylocaine	Lidocaine HCl
70518-0078	Xylocaine	Xylocaine
76478-479	Xylocaine	Xylocaine
52584-489	Xylocaine	Xylocaine
55154-9566	Xylocaine	Xylocaine
55154-9574	Xylocaine	Xylocaine
55154-9572	Xylocaine	Xylocaine
55154-9567	Xylocaine	Xylocaine
55154-9569	Xylocaine	Xylocaine
55154-9575	Xylocaine	Xylocaine
63323-482	Xylocaine	Xylocaine
63323-485	Xylocaine	Xylocaine
63323-486	Xylocaine	Xylocaine
63323-483	Xylocaine	Xylocaine
63323-481	Xylocaine	Xylocaine
63323-484	Xylocaine	Xylocaine
66312-176	Xylocaine	Xylocaine
66312-181	Xylocaine	Xylocaine
70518-2050	Xylocaine	Xylocaine
70518-2049	Xylocaine	Xylocaine