NDC 63323-487 – Xylocaine MPF
Lidocaine Hydrochloride Anhydrous 10 mg/mL; Epinephrine Bitartrate .005 mg/mL · Injection, Solution · Epidural, Infiltration, Intracaudal, Perineural
Product NDC63323-487
Product details
- Brand name
- Xylocaine MPF
- Generic name
- Lidocaine Hydrochloride
- Labeler
- Fresenius Kabi USA, LLC
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration, Intracaudal, 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 .005 mg/mL
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 63323-487-17 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-487-17) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-487-01) | Aug 12, 2010 |
| 63323-487-31 | 5 VIAL, SINGLE-DOSE in 1 CARTON (63323-487-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-487-03) | Aug 12, 2010 |
| 63323-487-37 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-487-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-487-07) | 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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