NDC 63323-482 – Xylocaine
Lidocaine Hydrochloride Anhydrous 10 mg/mL; Epinephrine Bitartrate .01 mg/mL · Injection, Solution · Infiltration, Perineural
Product NDC63323-482
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 10 mg/mL
- Epinephrine Bitartrate .01 mg/mL
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 63323-482-17 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-17) / 10 mL in 1 VIAL, MULTI-DOSE (63323-482-01) | Aug 12, 2010 |
| 63323-482-26 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-26) / 20 mL in 1 VIAL, MULTI-DOSE (63323-482-41) | Aug 12, 2010 |
| 63323-482-27 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-27) / 20 mL in 1 VIAL, MULTI-DOSE (63323-482-03) | Aug 12, 2010 |
| 63323-482-57 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-482-05) | 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.
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