FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
55154-3189
11-digit product format
551543189
Labeler code
55154
Product ID
55154-3189_dd92439e-5d8b-4c14-be94-54357c4c6b19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA040302
Marketing category
ANDA
Marketing start
2010-11-29
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1012068

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
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
55154-3189-5Lidocaine Hydrochloride5 in 1 BAGINJECTION, SOLUTION512
55154-3189-5Lidocaine Hydrochloride5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION512

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]3
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3189LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]11Current NDC, Legacy NDC, 2 package rows20250110_4e46cac7-00cd-4a01-ba11-9af4960cfbe9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012068lidocaine HCl 2 % in 5 ML Prefilled SyringePSN4e46cac7-00cd-4a01-ba11-9af4960cfbe912
10120685 ML lidocaine hydrochloride 20 MG/ML Prefilled SyringeSCD4e46cac7-00cd-4a01-ba11-9af4960cfbe912
1012068lidocaine HCl 100 MG per 5 ML Prefilled SyringeSY4e46cac7-00cd-4a01-ba11-9af4960cfbe912
1012068lidocaine HCl 2 % per 5 ML Prefilled SyringeSY4e46cac7-00cd-4a01-ba11-9af4960cfbe912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55154-3189-5551543189055 SYRINGE, PLASTIC in 1 BAG (55154-3189-5) / 5 mL in 1 SYRINGE, PLASTIC2010-11-29NoNoCurrent