FDA.reportPublic FDA data

lidocaine hydrochloride

Product NDC
83634-651
11-digit product format
836340651
Labeler code
83634
Product ID
83634-651_8fb1dd7b-f349-4a64-96c1-bd72bf748f3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Avenacy, LLC
Application
ANDA219535
Marketing category
ANDA
Marketing start
2025-07-01
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
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 HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010033, 1737562, 1737566, 1737568

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83634-651-10lidocaine hydrochloride25 in 1 CARTONINJECTION, SOLUTION254
83634-651-20lidocaine hydrochloride25 in 1 CARTONINJECTION, SOLUTION254
83634-651-41lidocaine hydrochloride10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION104
83634-651-42lidocaine hydrochloride20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION204
83634-651-43lidocaine hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION504
83634-651-50lidocaine hydrochloride25 in 1 CARTONINJECTION, SOLUTION254

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737568lidocaine HCl 1 % in 2 ML InjectionPSN46480253-29b9-4d7f-98ed-10377929026b4
1737562lidocaine HCl 1 % in 30 ML InjectionPSN46480253-29b9-4d7f-98ed-10377929026b4
1737566lidocaine HCl 1 % in 5 ML InjectionPSN46480253-29b9-4d7f-98ed-10377929026b4
1010033lidocaine HCl 1 % Injectable SolutionPSN46480253-29b9-4d7f-98ed-10377929026b4
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD46480253-29b9-4d7f-98ed-10377929026b4
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCD46480253-29b9-4d7f-98ed-10377929026b4
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD46480253-29b9-4d7f-98ed-10377929026b4
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD46480253-29b9-4d7f-98ed-10377929026b4
1737568lidocaine HCl 1 % per 2 ML InjectionSY46480253-29b9-4d7f-98ed-10377929026b4
1737562lidocaine HCl 1 % per 30 ML InjectionSY46480253-29b9-4d7f-98ed-10377929026b4
1737566lidocaine HCl 1 % per 5 ML InjectionSY46480253-29b9-4d7f-98ed-10377929026b4
1737568lidocaine HCl 20 MG per 2 ML InjectionSY46480253-29b9-4d7f-98ed-10377929026b4
1737562lidocaine HCl 300 MG per 30 ML InjectionSY46480253-29b9-4d7f-98ed-10377929026b4
1737566lidocaine HCl 50 MG per 5 ML InjectionSY46480253-29b9-4d7f-98ed-10377929026b4
1010033lidocaine hydrochloride 1 % Injectable SolutionSY46480253-29b9-4d7f-98ed-10377929026b4
1010033lidocaine HCl 1 % Injectable SolutionPSN4643042c-ec95-3bad-e063-6294a90a82501
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD4643042c-ec95-3bad-e063-6294a90a82501
1010033lidocaine hydrochloride 1 % Injectable SolutionSY4643042c-ec95-3bad-e063-6294a90a82501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-651-108363406511025 VIAL, MULTI-DOSE in 1 CARTON (83634-651-10) / 10 mL in 1 VIAL, MULTI-DOSE (83634-651-41) 2026-02-15NoNoCurrent
83634-651-208363406512025 VIAL, MULTI-DOSE in 1 CARTON (83634-651-20) / 20 mL in 1 VIAL, MULTI-DOSE (83634-651-42) 2026-02-15NoNoCurrent
83634-651-418363406514110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
83634-651-428363406514220 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
83634-651-438363406514350 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
83634-651-508363406515025 VIAL, MULTI-DOSE in 1 CARTON (83634-651-50) / 50 mL in 1 VIAL, MULTI-DOSE (83634-651-43) 2025-07-01NoNoCurrent