FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
62135-871
11-digit product format
621350871
Labeler code
62135
Product ID
62135-871_4936d399-9101-8558-e063-6294a90a639c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
OROPHARYNGEAL
Labeler
Chartwell RX, LLC
Application
ANDA040708
Marketing category
ANDA
Marketing start
2007-02-27
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
Rxcui1010739

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
62135-871-24Lidocaine Hydrochloride10 in 1 TRAYSOLUTION103
62135-871-24Lidocaine Hydrochloride2 in 1 BOXSOLUTION23
62135-871-51Lidocaine Hydrochloride15 mL in 1 CUPSOLUTION153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-871-24ML - Milliliter62135-8715eedb87d-fb43-484a-97c0-1699f68cd1e012024-09-09
62135-871-51ML - Milliliter62135-871f6a383ed-dcbf-492f-93e2-e8ad9e275f9812024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-871LIDOCAINE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC]2Current NDC, 3 package rows20240612_c05f49a2-7512-48e7-9730-f8ee05519b9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSNc05f49a2-7512-48e7-9730-f8ee05519b9d3
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCDc05f49a2-7512-48e7-9730-f8ee05519b9d3
1010739lidocaine HCl 2 % Oral Topical SolutionSYc05f49a2-7512-48e7-9730-f8ee05519b9d3
1010739lidocaine HCl 2 % Oromucosal SolutionSYc05f49a2-7512-48e7-9730-f8ee05519b9d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-871-24621350871242 TRAY in 1 BOX (62135-871-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (62135-871-51) 2 tray2024-05-31NoNoCurrent
62135-871-516213508715115 mL in 1 CUP15 mlHistorical