FDA.reportPublic FDA data

Lidocaine Hydrochloride and Epinephrine

Product NDC
0409-3182
11-digit product format
004093182
Labeler code
0409
Product ID
0409-3182_c8636a3b-5a45-4584-a9ea-85f506901337
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE and EPINEPHRINE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Hospira, Inc.
Application
ANDA089646
Marketing category
ANDA
Marketing start
2005-06-23
Substance
EPINEPHRINE; 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride and Epinephrine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE10 ug/mL
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH, V13007Z41A
Rxcui1010688, 1010745, 1010751, 1010759, 1867996, 1867998

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
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9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
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3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
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4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-3182-01Lidocaine Hydrochloride and Epinephrine25 in 1 TRAYINJECTION, SOLUTION2534
0409-3182-02Lidocaine Hydrochloride and Epinephrine25 in 1 TRAYINJECTION, SOLUTION2534
0409-3182-03Lidocaine Hydrochloride and Epinephrine25 in 1 TRAYINJECTION, SOLUTION2534
0409-3182-11Lidocaine Hydrochloride and Epinephrine20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2034
0409-3182-21Lidocaine Hydrochloride and Epinephrine30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION3034
0409-3182-31Lidocaine Hydrochloride and Epinephrine50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3182-01ML - Milliliter0409-31821f85ba0b-e5f7-4ca5-b671-0461b972aaf112012-07-24
0409-3182-02ML - Milliliter0409-3182b0b52315-4a58-46e2-a1ec-71324f9e85ca12012-07-24
0409-3182-03ML - Milliliter0409-318221ac8cbf-7757-4658-b8a0-65ca70c2232112012-07-24
0409-3182-11ML - Milliliter0409-318237bc8950-6ed4-4481-87b9-e0b5bafadbda12020-02-13
0409-3182-21ML - Milliliter0409-3182cc969438-80ef-4a63-b39d-1e7e9f2fe1d612020-02-13
0409-3182-31ML - Milliliter0409-31826ddd7598-320a-42e7-b2b5-db004c73e55b12020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BHLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
EPINEPHRINEACTIVE MOIETYYKH834O4BHLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
EPINEPHRINEACTIVE INGREDIENTYKH834O4BHLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND EPINEPHRINE) INJECTION, SOLUTION [US MEDSOURCE, LLC]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND EPINEPHRINE) INJECTION, SOLUTION [US MEDSOURCE, LLC]1
EPINEPHRINEACTIVE MOIETYYKH834O4BHLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND EPINEPHRINE) INJECTION, SOLUTION [US MEDSOURCE, LLC]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND EPINEPHRINE) INJECTION, SOLUTION [US MEDSOURCE, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND EPINEPHRINE) INJECTION, SOLUTION [US MEDSOURCE, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND EPINEPHRINE) INJECTION, SOLUTION [US MEDSOURCE, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND EPINEPHRINE) INJECTION, SOLUTION [US MEDSOURCE, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND EPINEPHRINE) INJECTION, SOLUTION [US MEDSOURCE, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND EPINEPHRINE) INJECTION, SOLUTION [US MEDSOURCE, LLC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND EPINEPHRINE) INJECTION, SOLUTION [US MEDSOURCE, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND EPINEPHRINE) INJECTION, SOLUTION [US MEDSOURCE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3182LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]32Current NDC, Legacy NDC, 6 package rows20250510_2f94f711-14c4-48ec-c5a3-c5ec4b8e8729.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010745lidocaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSN2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1867996lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1867998lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 5 ML InjectionPSN2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010759lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable SolutionPSN2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010688lidocaine HCl 2 % / EPINEPHrine 1:200,000 in 20 ML InjectionPSN2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
101068820 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML InjectionSCD2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
186799630 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML InjectionSCD2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
18679985 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML InjectionSCD2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010745epinephrine 0.005 MG/ML / lidocaine hydrochloride 5 MG/ML Injectable SolutionSCD2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010759epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010759epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010745epinephrine (as epinephrine bitartrate) 1:200,000 / lidocaine hydrochloride 0.5 % Injectable SolutionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010759epinephrine 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010745lidocaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1867996lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 per 30 ML InjectionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1867998lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 per 5 ML InjectionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010688lidocaine HCl 2 % / EPINEPHrine 1:200,000 per 20 ML InjectionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010759lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable SolutionPSNe0e621d2-10b0-4cdf-b31d-c19b1e86ba6b12
1010759epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable SolutionSCDe0e621d2-10b0-4cdf-b31d-c19b1e86ba6b12
1010759epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSYe0e621d2-10b0-4cdf-b31d-c19b1e86ba6b12
1010759epinephrine 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSYe0e621d2-10b0-4cdf-b31d-c19b1e86ba6b12
1010759lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable SolutionPSNa09613b2-4337-5b52-e053-2995a90ab74b7
1010759epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable SolutionSCDa09613b2-4337-5b52-e053-2995a90ab74b7
1010759epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSYa09613b2-4337-5b52-e053-2995a90ab74b7
1010759epinephrine 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSYa09613b2-4337-5b52-e053-2995a90ab74b7
1010759lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable SolutionPSNa098ab6c-143f-77a5-e053-2a95a90a3e0a6
1010759epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable SolutionSCDa098ab6c-143f-77a5-e053-2a95a90a3e0a6
1010759epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSYa098ab6c-143f-77a5-e053-2a95a90a3e0a6
1010759epinephrine 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSYa098ab6c-143f-77a5-e053-2a95a90a3e0a6
1010759lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable SolutionPSN43048b6b-3c83-eef4-e063-6294a90a34cb2
1010759epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD43048b6b-3c83-eef4-e063-6294a90a34cb2
1010759epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSY43048b6b-3c83-eef4-e063-6294a90a34cb2
1010759epinephrine 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSY43048b6b-3c83-eef4-e063-6294a90a34cb2
1010759lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable SolutionPSNd2d1773a-1365-42bf-bded-c2dafe3fee771
1010759epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable SolutionSCDd2d1773a-1365-42bf-bded-c2dafe3fee771
1010759epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSYd2d1773a-1365-42bf-bded-c2dafe3fee771
1010759epinephrine 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSYd2d1773a-1365-42bf-bded-c2dafe3fee771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3182-010040931820125 VIAL, MULTI-DOSE in 1 TRAY (0409-3182-01) / 20 mL in 1 VIAL, MULTI-DOSE (0409-3182-11) 2005-09-150000-00-00NoNoCurrent
0409-3182-020040931820225 VIAL, MULTI-DOSE in 1 TRAY (0409-3182-02) / 30 mL in 1 VIAL, MULTI-DOSE (0409-3182-21) 2005-12-290000-00-00NoNoCurrent
0409-3182-030040931820325 VIAL, MULTI-DOSE in 1 TRAY (0409-3182-03) / 50 mL in 1 VIAL, MULTI-DOSE (0409-3182-31) 2005-06-230000-00-00NoNoCurrent
0409-3182-110040931821120 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
0409-3182-210040931822130 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
0409-3182-310040931823150 mL in 1 VIAL, MULTI-DOSE50 mlHistorical