FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
70518-4176
11-digit product format
705184176
Labeler code
70518
Product ID
70518-4176_3fba1106-c179-3e9e-e063-6394a90a1cff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA083173
Marketing category
ANDA
Marketing start
2024-09-18
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
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 HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1012068

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
70518-4176-0Lidocaine Hydrochloride10 in 1 PACKAGEINJECTION104
70518-4176-1Lidocaine Hydrochloride5 mL in 1 SYRINGEINJECTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4176LIDOCAINE HYDROCHLORIDE INJECTION [REMEDYREPACK INC.]3Current NDC, 2 package rows20250425_f824b48c-7039-4ce1-b3df-b3597aba5beb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012068lidocaine HCl 2 % in 5 ML Prefilled SyringePSNf824b48c-7039-4ce1-b3df-b3597aba5beb4
10120685 ML lidocaine hydrochloride 20 MG/ML Prefilled SyringeSCDf824b48c-7039-4ce1-b3df-b3597aba5beb4
1012068lidocaine HCl 100 MG per 5 ML Prefilled SyringeSYf824b48c-7039-4ce1-b3df-b3597aba5beb4
1012068lidocaine HCl 2 % per 5 ML Prefilled SyringeSYf824b48c-7039-4ce1-b3df-b3597aba5beb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4176-07051841760010 SYRINGE in 1 PACKAGE (70518-4176-0) / 5 mL in 1 SYRINGE (70518-4176-1) 10 syringe2024-09-18NoNoHistorical
70518-4176-1705184176015 mL in 1 SYRINGE5 mlHistorical