NDC 63323-481 – Xylocaine
Lidocaine Hydrochloride Anhydrous 5 mg/mL; Epinephrine Bitartrate .005 mg/mL · Injection, Solution · Infiltration, Perineural
Product NDC63323-481
Product details
- Brand name
- Xylocaine
- Generic name
- Lidocaine Hydrochloride,epinephrine Bitartrate
- Labeler
- Fresenius Kabi USA, LLC
- Dosage form
- Injection, Solution
- Route
- Infiltration, Perineural
- Marketing category
- NDA · NDA006488
- Marketed since
- August 12, 2010
- Listing expires
- December 31, 2026
- Pharmacologic class
- Amide Local Anesthetic; Antiarrhythmic; Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist
Active ingredients
- Lidocaine Hydrochloride Anhydrous 5 mg/mL
- Epinephrine Bitartrate .005 mg/mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 63323-481-57 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-481-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-481-01) | Aug 12, 2010 |
Recalls mentioning this NDC
- D-0728-2026 Jul 29, 2026 · Class II
Presence of Particulate Matter: Hair was found in products - D-0729-2026 Jul 29, 2026 · Class II
Presence of Particulate Matter: Hair was found in products - D-1052-2022 Jun 15, 2022 · Class II
cGMP deviations: Temperature abuse - D-1053-2022 Jun 15, 2022 · Class II
cGMP deviations: Temperature abuse - D-0651-2021 Jul 14, 2021 · Class II
Low out of specification results for epinephrine assay.
Other Xylocaine products
- 50090-6851 Lidocaine Hydrochloride Anhydrous 20 mg/mL; Epinephrine Bitartrate… · Injection, Solution · A-S Medication Solutions
- 76420-369 Lidocaine Hydrochloride Anhydrous 20 mg/mL · Injection, Solution · Asclemed USA, Inc.
- 66312-181 Lidocaine Hydrochloride 20 mg/mL; Epinephrine Bitartrate 20 ug/mL · Injection, Solution · Dentsply Pharmaceutical
- 66312-176 Lidocaine Hydrochloride 20 mg/mL; Epinephrine Bitartrate 10 ug/mL · Injection, Solution · Dentsply Pharmaceutical
- 63323-491 Lidocaine Hydrochloride Anhydrous 5 mg/mL · Injection, Solution · Fresenius Kabi USA, LLC
- 63323-492 Lidocaine Hydrochloride Anhydrous 10 mg/mL · Injection, Solution · Fresenius Kabi USA, LLC
- 63323-488 Lidocaine Hydrochloride Anhydrous 15 mg/mL; Epinephrine Bitartrate… · Injection, Solution · Fresenius Kabi USA, LLC
- 63323-486 Lidocaine Hydrochloride Anhydrous 20 mg/mL · Injection, Solution · Fresenius Kabi USA, LLC
- 63323-485 Lidocaine Hydrochloride Anhydrous 10 mg/mL · Injection, Solution · Fresenius Kabi USA, LLC
- 63323-484 Lidocaine Hydrochloride Anhydrous 5 mg/mL · Injection, Solution · Fresenius Kabi USA, LLC
- 63323-482 Lidocaine Hydrochloride Anhydrous 10 mg/mL; Epinephrine Bitartrate… · Injection, Solution · Fresenius Kabi USA, LLC
- 63323-483 Lidocaine Hydrochloride Anhydrous 20 mg/mL; Epinephrine Bitartrate… · Injection, Solution · Fresenius Kabi USA, LLC