FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
0054-3505
11-digit product format
000543505
Labeler code
0054
Product ID
0054-3505_3996fa01-1f0c-41ab-8dc3-9a28246138c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA088803
Marketing category
ANDA
Marketing start
1985-04-03
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010878

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
0054-3505-47Lidocaine Hydrochloride50 mL in 1 BOTTLESOLUTION508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3505-47ML - Milliliter0054-350518e9f4f4-18c7-4da5-a083-9d31cd22e4f312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES,INC.]4
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES,INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES,INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES,INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-3505LIDOCAINE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 1 package rows20231215_c5d27da0-e495-4bb6-a7e1-8eaa6595eb71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010878lidocaine HCl 4 % Mucous Membrane Topical SolutionPSNc5d27da0-e495-4bb6-a7e1-8eaa6595eb718
1010878lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical SolutionSCDc5d27da0-e495-4bb6-a7e1-8eaa6595eb718
1010878lidocaine hydrochloride 4 % Mucous Membrane Topical SolutionSYc5d27da0-e495-4bb6-a7e1-8eaa6595eb718
1010878lidocaine hydrochloride 4 % Oromucosal SolutionSYc5d27da0-e495-4bb6-a7e1-8eaa6595eb718
1010878lidocaine HCl 4 % Mucous Membrane Topical SolutionPSN09c10cd0-b634-ab9d-e063-6294a90aa5442
1010878lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical SolutionSCD09c10cd0-b634-ab9d-e063-6294a90aa5442
1010878lidocaine hydrochloride 4 % Mucous Membrane Topical SolutionSY09c10cd0-b634-ab9d-e063-6294a90aa5442
1010878lidocaine hydrochloride 4 % Oromucosal SolutionSY09c10cd0-b634-ab9d-e063-6294a90aa5442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-3505-470005435054750 mL in 1 BOTTLE (0054-3505-47) 50 ml1985-04-030000-00-00NoNoCurrent