FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
0527-6004
11-digit product format
005276004
Labeler code
0527
Product ID
0527-6004_94508c6a-c451-46de-850c-a63f5152df01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA040710
Marketing category
ANDA
Marketing start
2007-02-27
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
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 HYDROCHLORIDE ANHYDROUS40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
Rxcui1010878

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-6004-80Lidocaine Hydrochloride1 in 1 CARTONSOLUTION117
0527-6004-80Lidocaine Hydrochloride50 mL in 1 BOTTLESOLUTION5017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-6004-80ML - Milliliter0527-6004d33ce720-1dfd-48e9-a971-b491a91eea6612019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-6004LIDOCAINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]15Current NDC, Legacy NDC, 2 package rows20230822_c3353e08-2a8c-4ace-ba89-114f7131b8de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010878lidocaine HCl 4 % Mucous Membrane Topical SolutionPSNf581248d-697d-4174-aa42-afdf4ecce02e104
1010878lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical SolutionSCDf581248d-697d-4174-aa42-afdf4ecce02e104
1010878lidocaine hydrochloride 4 % Mucous Membrane Topical SolutionSYf581248d-697d-4174-aa42-afdf4ecce02e104
1010878lidocaine hydrochloride 4 % Oromucosal SolutionSYf581248d-697d-4174-aa42-afdf4ecce02e104
1010878lidocaine HCl 4 % Mucous Membrane Topical SolutionPSNed43f2c3-606c-4998-8fca-ee9b13cd18db101
1010878lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical SolutionSCDed43f2c3-606c-4998-8fca-ee9b13cd18db101
1010878lidocaine hydrochloride 4 % Mucous Membrane Topical SolutionSYed43f2c3-606c-4998-8fca-ee9b13cd18db101
1010878lidocaine hydrochloride 4 % Oromucosal SolutionSYed43f2c3-606c-4998-8fca-ee9b13cd18db101
1010878lidocaine HCl 4 % Mucous Membrane Topical SolutionPSNc3353e08-2a8c-4ace-ba89-114f7131b8de17
1010878lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical SolutionSCDc3353e08-2a8c-4ace-ba89-114f7131b8de17
1010878lidocaine hydrochloride 4 % Mucous Membrane Topical SolutionSYc3353e08-2a8c-4ace-ba89-114f7131b8de17
1010878lidocaine hydrochloride 4 % Oromucosal SolutionSYc3353e08-2a8c-4ace-ba89-114f7131b8de17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-6004-80005276004801 BOTTLE in 1 CARTON (0527-6004-80) / 50 mL in 1 BOTTLE1 bottle2007-02-270000-00-00NoNoCurrent