Lidocaine hydrochloride

Product NDC
70518-4030
11-digit product format
705184030
Labeler code
70518
Product ID
70518-4030_4e6515ec-ac0e-058c-e063-6394a90a4c45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine hydrochloride
Dosage form
SOLUTION
Route
ORAL; TOPICAL
Labeler
REMEDYREPACK INC.
Application
ANDA216780
Marketing category
ANDA
Marketing start
2024-02-29
Substance
LIDOCAINE HYDROCHLORIDE
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 HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010739

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4030-0Lidocaine hydrochloride100 mL in 1 BOTTLESOLUTION1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4030LIDOCAINE HYDROCHLORIDE SOLUTION [REMEDYREPACK INC.]1Current NDC, 1 package rows20240301_adc4dd69-45f3-48fe-bf85-f014b384c38e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSNadc4dd69-45f3-48fe-bf85-f014b384c38e4
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCDadc4dd69-45f3-48fe-bf85-f014b384c38e4
1010739lidocaine HCl 2 % Oral Topical SolutionSYadc4dd69-45f3-48fe-bf85-f014b384c38e4
1010739lidocaine HCl 2 % Oromucosal SolutionSYadc4dd69-45f3-48fe-bf85-f014b384c38e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4030-070518403000100 mL in 1 BOTTLE (70518-4030-0) 100 ml2024-02-29NoNoHistorical