FDA.reportPublic FDA data

Lidocaine Hydrochloride and Epinephrine

Product NDC
0409-1209
11-digit product format
004091209
Labeler code
0409
Product ID
0409-1209_c8636a3b-5a45-4584-a9ea-85f506901337
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE and EPINEPHRINE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL
Labeler
Hospira, Inc.
Application
ANDA088571
Marketing category
ANDA
Marketing start
1985-09-13
Substance
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Active strength
5; 15 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
EPINEPHRINE5 ug/mL
LIDOCAINE HYDROCHLORIDE15 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1209-01Lidocaine Hydrochloride and Epinephrine10 in 1 TRAYINJECTION, SOLUTION1034
0409-1209-05Lidocaine Hydrochloride and Epinephrine5 mL in 1 AMPULEINJECTION, SOLUTION534
0409-1209-05Lidocaine Hydrochloride and Epinephrine400 in 1 CASEINJECTION, SOLUTION40034
0409-1209-10Lidocaine Hydrochloride and Epinephrine5 mL in 1 AMPULEINJECTION, SOLUTION534
0409-1209-65Lidocaine Hydrochloride and Epinephrine800 in 1 CASEINJECTION, SOLUTION80034
0409-1209-70Lidocaine Hydrochloride and Epinephrine5 mL in 1 AMPULEINJECTION, SOLUTION534
0409-1209-01OB GYN Procedure Kit5 mL in 1 AMPULEINJECTION, SOLUTION5 mL5 ug in 1mL1
0409-1209-01General Surgery Kit5 mL in 1 AMPULEINJECTION, SOLUTION5 mL5 ug in 1mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1209-01ML - Milliliter0409-120924c2f95e-e224-44a8-a8ad-07f8db5b288812012-07-24
0409-1209-05ML - Milliliter0409-120940dcac15-16ed-4f7b-a787-025fbad5aa4812022-06-06
0409-1209-10ML - Milliliter0409-1209a1c935ae-22ad-4aee-9b0c-d6205bbb570912020-02-13
0409-1209-65ML - Milliliter0409-1209a35276ed-bf81-4b1c-b888-6ce325173f8412017-04-05
0409-1209-70ML - Milliliter0409-1209a81825c7-6b04-4422-ba07-2623944b1d8f12020-02-13

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 INGREDIENTYKH834O4BHOB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1
EPINEPHRINEACTIVE INGREDIENTYKH834O4BHGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPOB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1
EPINEPHRINEACTIVE MOIETYYKH834O4BHOB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1
EPINEPHRINEACTIVE MOIETYYKH834O4BHGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]1
LIDOCAINEACTIVE MOIETY98PI200987GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]1
LIDOCAINEACTIVE MOIETY98PI200987OB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLOB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3COB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]1
WATERINACTIVE INGREDIENT059QF0KO0ROB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1
WATERINACTIVE INGREDIENT059QF0KO0RGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1209LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]32Current NDC, Legacy NDC, 6 package rows20250510_2f94f711-14c4-48ec-c5a3-c5ec4b8e8729.zip
0409-1209GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]1Current NDC, Legacy NDC20120924_fc5cafa6-9a20-4a1b-9227-d41db6cb5a97.zip
0409-1209OB GYN PROCEDURE KIT () KIT [CENTURION MEDICAL PRODUCTS]1Current NDC, Legacy NDC20120924_081f8334-5b72-429a-b7db-cf2dcc6e1337.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
1867998lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 5 ML InjectionPSNfc5cafa6-9a20-4a1b-9227-d41db6cb5a971
1867998lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 5 ML InjectionPSN081f8334-5b72-429a-b7db-cf2dcc6e13371
18679985 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML InjectionSCD081f8334-5b72-429a-b7db-cf2dcc6e13371
18679985 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML InjectionSCDfc5cafa6-9a20-4a1b-9227-d41db6cb5a971
1867998lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 per 5 ML InjectionSYfc5cafa6-9a20-4a1b-9227-d41db6cb5a971
1867998lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 per 5 ML InjectionSY081f8334-5b72-429a-b7db-cf2dcc6e13371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1209-010040912090110 AMPULE in 1 TRAY (0409-1209-01) / 5 mL in 1 AMPULE (0409-1209-10) 10 ampule2006-02-020000-00-00NoNoCurrent
0409-1209-0500409120905400 AMPULE in 1 CASE (0409-1209-05) / 5 mL in 1 AMPULE400 ampule1985-09-130000-00-00NoNoCurrent
0409-1209-10004091209105 mL in 1 AMPULE5 mlHistorical
0409-1209-6500409120965800 AMPULE in 1 CASE (0409-1209-65) / 5 mL in 1 AMPULE (0409-1209-70) 800 ampule2005-03-310000-00-00NoNoCurrent
0409-1209-70004091209705 mL in 1 AMPULE5 mlHistorical