Xylocaine
- Product NDC
- 0404-9976
- 11-digit product format
- 004049976
- Labeler code
- 0404
- Product ID
- 0404-9976_94300f28-aabc-443a-9949-c59a45b134df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine Hydrochloride and epinephrine
- Dosage form
- INJECTION, SOLUTION
- Route
- INFILTRATION; PERINEURAL
- Labeler
- Henry Schein, Inc.
- Application
- NDA006488
- Marketing category
- NDA
- Marketing start
- 2022-01-10
- Substance
- EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
- Active strength
- .01; 20 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 | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 30Q7KI53AK, EC2CNF7XFP |
| Rxcui | 1010759, 1010763 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9976-20 | Xylocaine | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 6 |
| 0404-9976-20 | Xylocaine | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 6 |
| 0404-9976-50 | Xylocaine | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 6 |
| 0404-9976-50 | Xylocaine | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9976 | XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240602_6899113c-dee4-4227-9f68-475fcce6b91e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9976-20 | 00404997620 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9976-20) / 20 mL in 1 VIAL, MULTI-DOSE | 2022-01-10 | 0000-00-00 | No | No | Current |
| 0404-9976-50 | 00404997650 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9976-50) / 50 mL in 1 VIAL, MULTI-DOSE | 2022-01-10 | 0000-00-00 | No | No | Current |