FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
55150-253
11-digit product format
551500253
Labeler code
55150
Product ID
55150-253_0b1f03c2-db2f-4f90-acc0-d73abd731bf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Eugia US LLC
Application
ANDA207182
Marketing category
ANDA
Marketing start
2017-10-30
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

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
55150-253-50Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION256
55150-253-50Lidocaine Hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-253-50ML - Milliliter55150-2538daa13bd-5ec0-411c-b4c0-266e6e22f66012018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-253LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]6Current NDC, Legacy NDC, 2 package rows20240918_ef782e5e-e2d7-465a-99c6-b12611f3158c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSNef782e5e-e2d7-465a-99c6-b12611f3158c6
1010671lidocaine HCl 2 % Injectable SolutionPSNef782e5e-e2d7-465a-99c6-b12611f3158c6
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDef782e5e-e2d7-465a-99c6-b12611f3158c6
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCDef782e5e-e2d7-465a-99c6-b12611f3158c6
1010033lidocaine hydrochloride 1 % Injectable SolutionSYef782e5e-e2d7-465a-99c6-b12611f3158c6
1010671lidocaine hydrochloride 2 % Injectable SolutionSYef782e5e-e2d7-465a-99c6-b12611f3158c6
1010033lidocaine HCl 1 % Injectable SolutionPSNc8e7f9ef-1982-b8ce-e053-2a95a90ac4ee2
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDc8e7f9ef-1982-b8ce-e053-2a95a90ac4ee2
1010033lidocaine hydrochloride 1 % Injectable SolutionSYc8e7f9ef-1982-b8ce-e053-2a95a90ac4ee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-253-505515002535025 VIAL, MULTI-DOSE in 1 CARTON (55150-253-50) / 50 mL in 1 VIAL, MULTI-DOSE2017-10-300000-00-00NoNoCurrent