FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
72162-1098
11-digit product format
721621098
Labeler code
72162
Product ID
72162-1098_69a49b4b-2d3d-400f-8710-49029a33fbfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
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
72162-1098-2Lidocaine Hydrochloride50 mL in 1 BOTTLESOLUTION50101
72162-1098-2Lidocaine Hydrochloride1 in 1 CARTONSOLUTION1101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1098-2ML - Milliliter72162-10980bbf98f2-dd0b-4808-a8b9-8b54292adb4f12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1098LIDOCAINE HYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20250523_ed43f2c3-606c-4998-8fca-ee9b13cd18db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1098-2721621098021 BOTTLE in 1 CARTON (72162-1098-2) / 50 mL in 1 BOTTLE1 bottle2023-09-26NoNoHistorical