FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
83148-043
11-digit product format
831480043
Labeler code
83148
Product ID
83148-043_407bbf7a-4ffe-b9ec-e063-6394a90a76bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
The J. Molner Company LLC
Application
ANDA218411
Marketing category
ANDA
Marketing start
2024-11-01
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
83148-043-50Lidocaine Hydrochloride50 mL in 1 BOTTLESOLUTION505
83148-043-50Lidocaine Hydrochloride1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83148-043-50ML - Milliliter83148-043b12b25fa-c5f0-438b-9ff6-d0af670032fd12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83148-043LIDOCAINE HYDROCHLORIDE SOLUTION [THE J. MOLNER COMPANY LLC]4Current NDC, 2 package rows20241115_17880468-873f-6465-e063-6294a90a9c73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010878lidocaine HCl 4 % Mucous Membrane Topical SolutionPSN850bdb6a-85d9-441d-8666-7a61311386b6100
1010878lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical SolutionSCD850bdb6a-85d9-441d-8666-7a61311386b6100
1010878lidocaine hydrochloride 4 % Mucous Membrane Topical SolutionSY850bdb6a-85d9-441d-8666-7a61311386b6100
1010878lidocaine hydrochloride 4 % Oromucosal SolutionSY850bdb6a-85d9-441d-8666-7a61311386b6100
1010878lidocaine HCl 4 % Mucous Membrane Topical SolutionPSN17880468-873f-6465-e063-6294a90a9c735
1010878lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical SolutionSCD17880468-873f-6465-e063-6294a90a9c735
1010878lidocaine hydrochloride 4 % Mucous Membrane Topical SolutionSY17880468-873f-6465-e063-6294a90a9c735
1010878lidocaine hydrochloride 4 % Oromucosal SolutionSY17880468-873f-6465-e063-6294a90a9c735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83148-043-50831480043501 BOTTLE in 1 CARTON (83148-043-50) / 50 mL in 1 BOTTLE1 bottle2024-11-01NoNoCurrent