| 0404-9974-20 |
0404-9974 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
Lidocaine HCl |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20220117 |
N/A |
NDA |
NDA006488 |
Henry Schein, Inc. |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
1 VIAL in 1 BAG (0404-9974-20) / 20 mL in 1 VIAL |
| 0404-9974-50 |
0404-9974 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
Lidocaine HCl |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20220117 |
N/A |
NDA |
NDA006488 |
Henry Schein, Inc. |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
1 VIAL in 1 BAG (0404-9974-50) / 50 mL in 1 VIAL |
| 51662-1587-3 |
51662-1587 |
HUMAN PRESCRIPTION DRUG |
XYLOCAIN (LIDOCAINE HCl ) |
XYLOCAINE (LIDOCAINE HCl ) |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20220615 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
10 mg/mL |
25 POUCH in 1 CASE (51662-1587-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1587-2) / 50 mL in 1 VIAL, MULTI-DOSE (51662-1587-1) |
| 63323-481-57 |
63323-481 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.005 mg/mL; 5 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-481-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-481-01) |
| 63323-486-17 |
63323-486 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-486-17) / 10 mL in 1 VIAL, MULTI-DOSE (63323-486-01) |
| 63323-486-27 |
63323-486 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-486-27) / 20 mL in 1 VIAL, MULTI-DOSE (63323-486-02) |
| 63323-486-57 |
63323-486 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-486-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-486-05) |
| 63323-491-57 |
63323-491 |
HUMAN PRESCRIPTION DRUG |
Xylocaine MPF |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
INFILTRATION |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
5 mg/mL |
25 VIAL, SINGLE-DOSE in 1 TRAY (63323-491-57) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-491-01) |
| 63323-493-91 |
63323-493 |
HUMAN PRESCRIPTION DRUG |
Xylocaine MPF |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20110718 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
15 mg/mL |
5 AMPULE in 1 BOX (63323-493-91) / 20 mL in 1 AMPULE (63323-493-01) |
| 63323-493-97 |
63323-493 |
HUMAN PRESCRIPTION DRUG |
Xylocaine MPF |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20110718 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
15 mg/mL |
5 AMPULE in 1 BOX (63323-493-97) / 10 mL in 1 AMPULE (63323-493-03) |
| 70518-4152-1 |
70518-4152 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20240731 |
N/A |
NDA |
NDA006488 |
REMEDYREPACK INC. |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 10 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (70518-4152-1) / 20 mL in 1 VIAL, MULTI-DOSE (70518-4152-0) |
| 70518-4152-2 |
70518-4152 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20241004 |
N/A |
NDA |
NDA006488 |
REMEDYREPACK INC. |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 10 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (70518-4152-2) / 50 mL in 1 VIAL, MULTI-DOSE (70518-4152-3) |
| 63323-492-36 |
63323-492 |
HUMAN PRESCRIPTION DRUG |
Xylocaine MPF |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
10 mg/mL |
25 VIAL, SINGLE-DOSE in 1 CARTON (63323-492-36) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-492-43) |
| 63323-495-26 |
63323-495 |
HUMAN PRESCRIPTION DRUG |
Xylocaine MPF |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
25 VIAL, SINGLE-DOSE in 1 CARTON (63323-495-26) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-495-41) |
| 76420-408-10 |
76420-408 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20250620 |
N/A |
NDA |
NDA006488 |
ASCLEMED USA INC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
10 mL in 1 VIAL, MULTI-DOSE (76420-408-10) |
| 0404-9972-20 |
0404-9972 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
Lidocaine Hydrochloride and epinephrine |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20220110 |
N/A |
NDA |
NDA006488 |
Henry Schein, Inc. |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.005 mg/mL; 20 mg/mL |
1 VIAL in 1 BAG (0404-9972-20) / 20 mL in 1 VIAL |
| 0404-9976-20 |
0404-9976 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
Lidocaine Hydrochloride and epinephrine |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20220110 |
N/A |
NDA |
NDA006488 |
Henry Schein, Inc. |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 20 mg/mL |
1 VIAL, MULTI-DOSE in 1 BAG (0404-9976-20) / 20 mL in 1 VIAL, MULTI-DOSE |
| 85766-018-10 |
85766-018 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20250620 |
N/A |
NDA |
NDA006488 |
Sportpharm LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
10 mL in 1 VIAL, MULTI-DOSE (85766-018-10) |
| 65219-812-02 |
65219-812 |
HUMAN PRESCRIPTION DRUG |
Xylocaine MPF |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
20201030 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
25 VIAL, SINGLE-DOSE in 1 TRAY (65219-812-02) / 2 mL in 1 VIAL, SINGLE-DOSE (65219-812-01) |
| 63323-484-57 |
63323-484 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
5 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-484-57) / 50 mL in 1 VIAL, MULTI-DOSE |