| 0404-9977-20 |
0404-9977 |
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; 10 mg/mL |
1 VIAL in 1 BAG (0404-9977-20) / 20 mL in 1 VIAL |
| 0404-9977-50 |
0404-9977 |
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; 10 mg/mL |
1 VIAL in 1 BAG (0404-9977-50) / 50 mL in 1 VIAL |
| 63323-483-27 |
63323-483 |
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 |
.01 mg/mL; 20 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-483-27) / 20 mL in 1 VIAL, MULTI-DOSE (63323-483-03) |
| 63323-483-57 |
63323-483 |
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 |
.01 mg/mL; 20 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-483-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-483-01) |
| 52584-485-27 |
52584-485 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
Lidocaine Hydrochloride |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20181105 |
20260228 |
NDA |
NDA006488 |
General Injectables and Vaccines, inc. |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
10 mg/mL |
1 VIAL in 1 BAG (52584-485-27) / 20 mL in 1 VIAL |
| 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 |
| 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) |
| 51662-1505-1 |
51662-1505 |
HUMAN PRESCRIPTION DRUG |
LIDOCAINE HCI AND EPINEPHRINE |
LIDOCAINE HCI AND EPINEPHRINE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20200311 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 20 mg/mL |
50 mL in 1 VIAL, MULTI-DOSE (51662-1505-1) |
| 51662-1505-3 |
51662-1505 |
HUMAN PRESCRIPTION DRUG |
LIDOCAINE HCI AND EPINEPHRINE |
LIDOCAINE HCI AND EPINEPHRINE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20220317 |
N/A |
NDA |
NDA006488 |
HF Acquisition Co LLC, DBA HealthFirst |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 20 mg/mL |
25 POUCH in 1 CASE (51662-1505-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1505-2) / 50 mL in 1 VIAL, MULTI-DOSE |
| 52584-486-57 |
52584-486 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
Lidocaine HCl |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20111109 |
20260131 |
NDA |
NDA006488 |
General Injectables & Vaccines, Inc |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
1 VIAL in 1 BAG (52584-486-57) / 50 mL in 1 VIAL |
| 0404-9973-20 |
0404-9973 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
Lidocaine Hydrochloride |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20220110 |
N/A |
NDA |
NDA006488 |
Henry Schein, Inc. |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
10 mg/mL |
1 VIAL in 1 BAG (0404-9973-20) / 20 mL in 1 VIAL |
| 0404-9973-50 |
0404-9973 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
Lidocaine Hydrochloride |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20220110 |
N/A |
NDA |
NDA006488 |
Henry Schein, Inc. |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
10 mg/mL |
1 VIAL in 1 BAG (0404-9973-50) / 50 mL in 1 VIAL |
| 63323-485-26 |
63323-485 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20100812 |
N/A |
NDA |
NDA006488 |
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
10 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-485-26) / 20 mL in 1 VIAL, MULTI-DOSE (63323-485-41) |
| 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 |
| 0404-9976-50 |
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 (0404-9976-50) / 50 mL in 1 VIAL, MULTI-DOSE |
| 63323-482-17 |
63323-482 |
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 |
.01 mg/mL; 10 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-17) / 10 mL in 1 VIAL, MULTI-DOSE (63323-482-01) |
| 63323-482-27 |
63323-482 |
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 |
.01 mg/mL; 10 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-27) / 20 mL in 1 VIAL, MULTI-DOSE (63323-482-03) |
| 63323-482-57 |
63323-482 |
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 |
.01 mg/mL; 10 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-482-05) |
| 50090-6851-0 |
50090-6851 |
HUMAN PRESCRIPTION DRUG |
Xylocaine |
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
INJECTION, SOLUTION |
INFILTRATION; PERINEURAL |
20231129 |
N/A |
NDA |
NDA006488 |
A-S Medication Solutions |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS |
.01 mg/mL; 20 mg/mL |
25 VIAL, MULTI-DOSE in 1 TRAY (50090-6851-0) / 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, Inc. dba Sportpharm |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
20 mg/mL |
10 mL in 1 VIAL, MULTI-DOSE (85766-018-10) |