FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
50090-4557
11-digit product format
500904557
Labeler code
50090
Product ID
50090-4557_b4f0d554-f64e-437a-932f-30b72970e0b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA086364
Marketing category
ANDA
Marketing start
2012-06-19
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4557-02023-01-30C16284748780-1f386c64a-377d-0266-e053-dadaa90a7c1a6963000U LARYNG-O-JET ® LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION USP, 4% DISPOSABLE KIT WITH LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION FOR LARYNGOTRACHEAL ANESTHESIA Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4557-0Lidocaine Hydrochloride4 mL in 1 VIALSOLUTION42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4557-0ML - Milliliter50090-45579167d23c-b96d-4387-9ca7-7a9fea96065612022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4557LIDOCAINE HYDROCHLORIDE SOLUTION [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20191005_f52e2778-1f62-4435-a9de-62f502965eed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010878lidocaine HCl 4 % Mucous Membrane Topical SolutionPSNf52e2778-1f62-4435-a9de-62f502965eed2
1010878lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical SolutionSCDf52e2778-1f62-4435-a9de-62f502965eed2
1010878lidocaine hydrochloride 4 % Mucous Membrane Topical SolutionSYf52e2778-1f62-4435-a9de-62f502965eed2
1010878lidocaine hydrochloride 4 % Oromucosal SolutionSYf52e2778-1f62-4435-a9de-62f502965eed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4557-0500904557004 mL in 1 VIAL (50090-4557-0) 4 ml2019-09-250000-00-00NoNoCurrent