Lidocaine Hydrochloride

Product NDC
71351-021
11-digit product format
713510021
Labeler code
71351
Product ID
71351-021_470c127d-31e7-0299-e063-6394a90a2ad0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Brookfield Pharmaceuticals, LLC.
Application
ANDA212821
Marketing category
ANDA
Marketing start
2022-10-31
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010033, 1010671, 1737566, 1737761

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
71351-021-05Lidocaine Hydrochloride5 mL in 1 VIALSOLUTION55
71351-021-10Lidocaine Hydrochloride10 in 1 BOXSOLUTION105
71351-021-25Lidocaine Hydrochloride25 in 1 BOXSOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71351-021-05ML - Milliliter71351-021d588290b-3f86-41aa-9fd1-57e46a97654b12023-01-09
71351-021-10ML - Milliliter71351-021a4da9b95-fd5f-4cd6-8722-1b8cf4623cc012023-10-16
71351-021-25ML - Milliliter71351-02105f1233e-0c6a-4ebd-9ad5-dc8fc883c7b812023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71351-021LIDOCAINE HYDROCHLORIDE SOLUTION [BROOKFIELD PHARMACEUTICALS, LLC.]4Current NDC, Legacy NDC, 3 package rows20240209_e824ba5b-3289-5ad4-e053-2995a90acc20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737566lidocaine HCl 1 % in 5 ML InjectionPSNe824ba5b-3289-5ad4-e053-2995a90acc205
1010033lidocaine HCl 1 % Injectable SolutionPSNe824ba5b-3289-5ad4-e053-2995a90acc205
1737761lidocaine HCl 2 % in 5 ML InjectionPSNe824ba5b-3289-5ad4-e053-2995a90acc205
1010671lidocaine HCl 2 % Injectable SolutionPSNe824ba5b-3289-5ad4-e053-2995a90acc205
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDe824ba5b-3289-5ad4-e053-2995a90acc205
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCDe824ba5b-3289-5ad4-e053-2995a90acc205
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDe824ba5b-3289-5ad4-e053-2995a90acc205
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCDe824ba5b-3289-5ad4-e053-2995a90acc205
1737566lidocaine HCl 1 % per 5 ML InjectionSYe824ba5b-3289-5ad4-e053-2995a90acc205
1737761lidocaine HCl 100 MG per 5 ML InjectionSYe824ba5b-3289-5ad4-e053-2995a90acc205
1737761lidocaine HCl 2 % per 5 ML InjectionSYe824ba5b-3289-5ad4-e053-2995a90acc205
1737566lidocaine HCl 50 MG per 5 ML InjectionSYe824ba5b-3289-5ad4-e053-2995a90acc205
1010033lidocaine hydrochloride 1 % Injectable SolutionSYe824ba5b-3289-5ad4-e053-2995a90acc205
1010671lidocaine hydrochloride 2 % Injectable SolutionSYe824ba5b-3289-5ad4-e053-2995a90acc205

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71351-021-05713510021055 mL in 1 VIAL5 mlHistorical
71351-021-107135100211010 VIAL in 1 BOX (71351-021-10) / 5 mL in 1 VIAL (71351-021-05) 10 vial2022-10-310000-00-00NoNoCurrent
71351-021-257135100212525 VIAL in 1 BOX (71351-021-25) / 5 mL in 1 VIAL (71351-021-05) 25 vial2022-10-310000-00-00NoNoCurrent