FDA.reportPublic FDA data

Lidocaine Hydrochloride and Epinephrine

Product NDC
0409-3178
11-digit product format
004093178
Labeler code
0409
Product ID
0409-3178_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
ANDA089644
Marketing category
ANDA
Marketing start
2005-09-16
Substance
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Active strength
10; 10 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 HYDROCHLORIDE10 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
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49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
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e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
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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
0409-3178-01Lidocaine Hydrochloride and Epinephrine25 in 1 TRAYINJECTION, SOLUTION2534
0409-3178-02Lidocaine Hydrochloride and Epinephrine25 in 1 TRAYINJECTION, SOLUTION2534
0409-3178-03Lidocaine Hydrochloride and Epinephrine25 in 1 TRAYINJECTION, SOLUTION2534
0409-3178-16Lidocaine Hydrochloride and Epinephrine20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2034
0409-3178-17Lidocaine Hydrochloride and Epinephrine30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION3034
0409-3178-18Lidocaine Hydrochloride and Epinephrine50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5034
0409-3178-01Cardiovascular Procedure Kit10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION10 mL10 ug in 1mL1
0409-3178-01General Surgery Procedure Kit10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION10 mL10 ug in 1mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3178LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]32Current NDC, Legacy NDC, 6 package rows20250510_2f94f711-14c4-48ec-c5a3-c5ec4b8e8729.zip
0409-3178CARDIOVASCULAR PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1Current NDC, Legacy NDC20120925_f52a6d21-df93-4866-bdf4-2a83a50e0cf6.zip
0409-3178GENERAL SURGERY PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1Current NDC, Legacy NDC20120925_d0e11ec3-bb47-4c89-b8c2-6e053f0ce60d.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
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSNc3490a23-14c4-43f7-b066-96a4c4298fde10
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN77fd6ee4-108f-4525-8df5-7db9236042ee10
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDc3490a23-14c4-43f7-b066-96a4c4298fde10
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD77fd6ee4-108f-4525-8df5-7db9236042ee10
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSY77fd6ee4-108f-4525-8df5-7db9236042ee10
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSYc3490a23-14c4-43f7-b066-96a4c4298fde10
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSYc3490a23-14c4-43f7-b066-96a4c4298fde10
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSY77fd6ee4-108f-4525-8df5-7db9236042ee10
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN76176d50-a987-c9f9-e053-2991aa0aea0f8
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD76176d50-a987-c9f9-e053-2991aa0aea0f8
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSY76176d50-a987-c9f9-e053-2991aa0aea0f8
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSY76176d50-a987-c9f9-e053-2991aa0aea0f8
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN957506a5-1b09-0736-e053-2995a90a0b637
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN95309440-34ec-11fe-e053-2a95a90a1c907
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD95309440-34ec-11fe-e053-2a95a90a1c907
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD957506a5-1b09-0736-e053-2995a90a0b637
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSY957506a5-1b09-0736-e053-2995a90a0b637
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSY95309440-34ec-11fe-e053-2a95a90a1c907
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSY95309440-34ec-11fe-e053-2a95a90a1c907
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSY957506a5-1b09-0736-e053-2995a90a0b637
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN2c58deba-dbb2-4e73-a173-36053536f03e2
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD2c58deba-dbb2-4e73-a173-36053536f03e2
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSY2c58deba-dbb2-4e73-a173-36053536f03e2
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSY2c58deba-dbb2-4e73-a173-36053536f03e2
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN96773b3d-3eed-4bc9-aac0-18c185377cad1
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSNd0e11ec3-bb47-4c89-b8c2-6e053f0ce60d1
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSNf52a6d21-df93-4866-bdf4-2a83a50e0cf61
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD96773b3d-3eed-4bc9-aac0-18c185377cad1
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDd0e11ec3-bb47-4c89-b8c2-6e053f0ce60d1
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDf52a6d21-df93-4866-bdf4-2a83a50e0cf61
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSY96773b3d-3eed-4bc9-aac0-18c185377cad1
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSYd0e11ec3-bb47-4c89-b8c2-6e053f0ce60d1
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSYf52a6d21-df93-4866-bdf4-2a83a50e0cf61
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSY96773b3d-3eed-4bc9-aac0-18c185377cad1
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSYd0e11ec3-bb47-4c89-b8c2-6e053f0ce60d1
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSYf52a6d21-df93-4866-bdf4-2a83a50e0cf61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3178-010040931780125 VIAL, MULTI-DOSE in 1 TRAY (0409-3178-01) / 20 mL in 1 VIAL, MULTI-DOSE (0409-3178-16) 2005-09-160000-00-00NoNoCurrent
0409-3178-020040931780225 VIAL, MULTI-DOSE in 1 TRAY (0409-3178-02) / 30 mL in 1 VIAL, MULTI-DOSE (0409-3178-17) 2005-09-270000-00-00NoNoCurrent
0409-3178-030040931780325 VIAL, MULTI-DOSE in 1 TRAY (0409-3178-03) / 50 mL in 1 VIAL, MULTI-DOSE (0409-3178-18) 2005-09-190000-00-00NoNoCurrent
0409-3178-160040931781620 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
0409-3178-170040931781730 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
0409-3178-180040931781850 mL in 1 VIAL, MULTI-DOSE50 mlHistorical