Lidocaine

Product NDC
66467-9710
11-digit product format
664679710
Labeler code
66467
Product ID
66467-9710_adf7d4fa-55d8-43d3-ab50-11f6cebeda1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride and Epinephrine Bitartrate
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Darby Dental Supply, LLC
Application
ANDA088389
Marketing category
ANDA
Marketing start
2011-01-14
Substance
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
Active strength
.02; 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
Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE BITARTRATE.02 mg/mL
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30Q7KI53AK, V13007Z41A
Rxcui1657026

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66467-9710-5Lidocaine50 in 1 CARTONINJECTION, SOLUTION505
66467-9710-5Lidocaine1.7 mL in 1 CARTRIDGEINJECTION, SOLUTION1.75

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Epinephrine BitartrateACTIVE INGREDIENT30Q7KI53AKLIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DARBY DENTAL SUPPLY, LLC]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ALIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DARBY DENTAL SUPPLY, LLC]1
EpinephrineACTIVE MOIETYYKH834O4BHLIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DARBY DENTAL SUPPLY, LLC]1
LidocaineACTIVE MOIETY98PI200987LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DARBY DENTAL SUPPLY, LLC]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KLIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DARBY DENTAL SUPPLY, LLC]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBLIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DARBY DENTAL SUPPLY, LLC]1
Potassium MetabisulfiteINACTIVE INGREDIENT65OE787Q7WLIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DARBY DENTAL SUPPLY, LLC]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XLIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DARBY DENTAL SUPPLY, LLC]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ILIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DARBY DENTAL SUPPLY, LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RLIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DARBY DENTAL SUPPLY, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66467-9710LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DARBY DENTAL SUPPLY, LLC]5Current NDC, Legacy NDC, 2 package rows20240206_27e8fdfb-e923-4f99-aff7-8b9e50228151.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657026lidocaine HCl 2 % with EPINEPHrine 1:50,000 in 1.7 ML Dental CartridgePSN27e8fdfb-e923-4f99-aff7-8b9e502281515
16570261.7 ML epinephrine 0.02 MG/ML / lidocaine hydrochloride 20 MG/ML CartridgeSCD27e8fdfb-e923-4f99-aff7-8b9e502281515
1657026epinephrine 1:50,000 / lidocaine HCl 2 % 1.7 ML CartridgeSY27e8fdfb-e923-4f99-aff7-8b9e502281515
1657026lidocaine HCl 2 % with epinephrine 1:50,000 1.7 ML Dental CartridgeSY27e8fdfb-e923-4f99-aff7-8b9e502281515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66467-9710-56646797100550 CARTRIDGE in 1 CARTON (66467-9710-5) / 1.7 mL in 1 CARTRIDGE50 cartridge2011-01-140000-00-00NoNoCurrent