Xylocaine
- Product NDC
- 70518-4152
- 11-digit product format
- 705184152
- Labeler code
- 70518
- Product ID
- 70518-4152_40bbf18f-8948-ef62-e063-6394a90aa2d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INFILTRATION; PERINEURAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA006488
- Marketing category
- NDA
- Marketing start
- 2024-07-31
- Substance
- EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
- Active strength
- .01; 10 mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Xylocaine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPINEPHRINE BITARTRATE | .01 mg/mL |
| LIDOCAINE HYDROCHLORIDE ANHYDROUS | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 30Q7KI53AK, EC2CNF7XFP |
| Rxcui | 1010751, 1010755 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4152-0 | Xylocaine | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 5 |
| 70518-4152-1 | Xylocaine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 5 |
| 70518-4152-2 | Xylocaine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 5 |
| 70518-4152-3 | Xylocaine | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4152 | XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [REMEDYREPACK INC.] | 2 | Current NDC, 4 package rows | 20250116_1414bcfc-1543-4ad4-83bd-4fc444a02e92.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4152-0 | 70518415200 | 20 mL in 1 VIAL, MULTI-DOSE | 20 ml | | | | Historical |
| 70518-4152-1 | 70518415201 | 25 VIAL, MULTI-DOSE in 1 TRAY (70518-4152-1) / 20 mL in 1 VIAL, MULTI-DOSE (70518-4152-0) | | 2024-07-31 | No | No | Historical |
| 70518-4152-2 | 70518415202 | 25 VIAL, MULTI-DOSE in 1 TRAY (70518-4152-2) / 50 mL in 1 VIAL, MULTI-DOSE (70518-4152-3) | | 2024-10-04 | No | No | Historical |
| 70518-4152-3 | 70518415203 | 50 mL in 1 VIAL, MULTI-DOSE | 50 ml | | | | Historical |