FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
51672-1411
11-digit product format
516721411
Labeler code
51672
Product ID
51672-1411_39623a94-8b8c-17c6-e063-6294a90a4c31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA218182
Marketing category
ANDA
Marketing start
2023-12-08
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010878

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51672-1411-32025-03-17C16284748780-12cef2736-619e-d83d-e063-dadaa90ab31fLIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP
51672-1411-32025-01-30C16284748780-12cef2736-619e-d83d-e063-dadaa90ab31fLIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1411-3Lidocaine Hydrochloride1 in 1 CARTONSOLUTION15
51672-1411-3Lidocaine Hydrochloride50 mL in 1 BOTTLESOLUTION505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1411-3ML - Milliliter51672-14114934600f-7817-49a5-af2c-21b5a001d0e512024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1411LIDOCAINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, 2 package rows20250321_845b96c1-36a3-431f-8316-112ae881d934.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010878lidocaine HCl 4 % Mucous Membrane Topical SolutionPSN845b96c1-36a3-431f-8316-112ae881d9345
1010878lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical SolutionSCD845b96c1-36a3-431f-8316-112ae881d9345
1010878lidocaine hydrochloride 4 % Mucous Membrane Topical SolutionSY845b96c1-36a3-431f-8316-112ae881d9345
1010878lidocaine hydrochloride 4 % Oromucosal SolutionSY845b96c1-36a3-431f-8316-112ae881d9345

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-1411-3516721411031 BOTTLE in 1 CARTON (51672-1411-3) / 50 mL in 1 BOTTLE1 bottle2023-12-08NoNoHistorical