Xylocaine
- Product NDC
- 66312-176
- 11-digit product format
- 663120176
- Labeler code
- 66312
- Product ID
- 66312-176_5b7b5a3e-e9fe-4dd1-949f-d3cac9755bb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine Hydrochloride and Epinephrine Bitartrate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Labeler
- Dentsply Pharmaceutical
- Application
- ANDA088390
- Marketing category
- ANDA
- Marketing start
- 1985-01-22
- Substance
- EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
- Active strength
- 10; 20 ug/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 | 10 ug/mL |
| LIDOCAINE HYDROCHLORIDE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 30Q7KI53AK, V13007Z41A |
| Rxcui | 1010768, 1293648, 1608499, 1657026 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66312-176-16 | Xylocaine | 50 in 1 CARTON | INJECTION, SOLUTION | 50 | | 9 |
| 66312-176-16 | Xylocaine | 1.7 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.7 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Epinephrine Bitartrate | ACTIVE INGREDIENT | 30Q7KI53AK | XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 4 | |
| Lidocaine Hydrochloride | ACTIVE INGREDIENT | V13007Z41A | XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 4 | |
| Epinephrine | ACTIVE MOIETY | YKH834O4BH | XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 4 | |
| Lidocaine | ACTIVE MOIETY | 98PI200987 | XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 4 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 4 | |
| Hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 4 | |
| Potassium Bisulfite | INACTIVE INGREDIENT | QJK5LO891P | XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 4 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 4 | |
| Sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 4 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66312-176 | XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240206_14b55cf9-f7cd-4bb4-a7c5-aba61abadef1.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1293648 | lidocaine HCl 2 % / EPINEPHrine 1:100,000 in 1.7 mL Dental Cartridge | PSN | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1657026 | lidocaine HCl 2 % with EPINEPHrine 1:50,000 in 1.7 ML Dental Cartridge | PSN | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1608499 | Xylocaine 2 % with EPINEPHrine 1:100,000 in 1.7 mL Dental Cartridge | PSN | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1010768 | Xylocaine 2 % with EPINEPHrine 1:50,000 in 1.7 mL Dental Cartridge | PSN | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1608499 | 1.7 ML epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Cartridge [Xylocaine with Epinephrine] | SBD | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1010768 | 1.7 ML epinephrine 0.02 MG/ML / lidocaine hydrochloride 20 MG/ML Cartridge [Xylocaine with Epinephrine] | SBD | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1293648 | 1.7 ML epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Cartridge | SCD | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1657026 | 1.7 ML epinephrine 0.02 MG/ML / lidocaine hydrochloride 20 MG/ML Cartridge | SCD | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1657026 | epinephrine 1:50,000 / lidocaine HCl 2 % 1.7 ML Cartridge | SY | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1293648 | lidocaine HCl 2 % / epinephrine 1:100,000 1.7 ML Dental Cartridge | SY | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1293648 | lidocaine HCl 2 % with epinephrine 1:100,000 1.7 ML Dental Cartridge | SY | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1657026 | lidocaine HCl 2 % with epinephrine 1:50,000 1.7 ML Dental Cartridge | SY | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1608499 | Xylocaine with Epinephrine (lidocaine HCl 2 % / epinephrine 1:100,000) 1.7 ML Dental Cartridge | SY | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
| 1010768 | Xylocaine with Epinephrine (lidocaine HCl 2 % / epinephrine 1:50,000) 1.7 ML Dental Cartridge | SY | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 9 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66312-176-16 | 66312017616 | 50 CARTRIDGE in 1 CARTON (66312-176-16) / 1.7 mL in 1 CARTRIDGE | 50 cartridge | 2009-04-14 | 0000-00-00 | No | No | Current |