FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
50090-0258
11-digit product format
500900258
Labeler code
50090
Product ID
50090-0258_ad928dd8-d78b-40a2-a018-c437a3ec9a93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
A-S Medication Solutions
Application
ANDA088299
Marketing category
ANDA
Marketing start
2005-07-12
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

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
50090-0258-02023-02-07C16284748780-1f386c64a-0e83-0266-e053-dadaa90a7c1aLidocaine Hydrochloride Injection, USP
50090-0258-12023-02-07C16284748780-1f386c64a-0e83-0266-e053-dadaa90a7c1aLidocaine Hydrochloride Injection, USP
50090-0258-22023-02-07C16284748780-1f386c64a-0e83-0266-e053-dadaa90a7c1aLidocaine Hydrochloride Injection, USP
50090-0258-02023-01-30C16284748780-1f386c64a-0e83-0266-e053-dadaa90a7c1aLidocaine Hydrochloride Injection, USP
50090-0258-12023-01-30C16284748780-1f386c64a-0e83-0266-e053-dadaa90a7c1aLidocaine Hydrochloride Injection, USP
50090-0258-22023-01-30C16284748780-1f386c64a-0e83-0266-e053-dadaa90a7c1aLidocaine Hydrochloride Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0258-0Lidocaine Hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5023
50090-0258-0Lidocaine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION2523
50090-0258-1Lidocaine Hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5023
50090-0258-1Lidocaine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION2523
50090-0258-2Lidocaine Hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0258-1ML - Milliliter50090-02584406882c-00e7-49a4-812a-d15e7ed4d70112018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0258LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]21Current NDC, Legacy NDC, 5 package rows20230208_82b377ee-0e3e-4cb9-a644-f45434c21cca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSN82b377ee-0e3e-4cb9-a644-f45434c21cca23
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD82b377ee-0e3e-4cb9-a644-f45434c21cca23
1010033lidocaine hydrochloride 1 % Injectable SolutionSY82b377ee-0e3e-4cb9-a644-f45434c21cca23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0258-05009002580050 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
50090-0258-15009002580125 VIAL, MULTI-DOSE in 1 TRAY (50090-0258-1) / 50 mL in 1 VIAL, MULTI-DOSE2016-06-290000-00-00NoNoCurrent
50090-0258-25009002580250 mL in 1 VIAL, MULTI-DOSE (50090-0258-2) 50 ml2019-09-260000-00-00NoNoCurrent