Lidocaine Hydrochloride

Product NDC
0404-9888
11-digit product format
004049888
Labeler code
0404
Product ID
0404-9888_32174e9e-9c08-4149-baae-f754e838d50e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride Anhydrous
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Henry Schein, Inc.
Application
ANDA088299
Marketing category
ANDA
Marketing start
2022-01-12
Marketing end
2027-03-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9888-20Lidocaine Hydrochloride20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2013
0404-9888-20Lidocaine Hydrochloride1 in 1 BAGINJECTION, SOLUTION113
0404-9888-50Lidocaine Hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5013
0404-9888-50Lidocaine Hydrochloride1 in 1 BAGINJECTION, SOLUTION113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9888LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE ANHYDROUS) INJECTION, SOLUTION [HENRY SCHEIN, INC.]11Current NDC, Legacy NDC, 4 package rows20241215_07a2b40b-0386-40d4-b0c4-e69e13610cd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSN07a2b40b-0386-40d4-b0c4-e69e13610cd913
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD07a2b40b-0386-40d4-b0c4-e69e13610cd913
1010033lidocaine hydrochloride 1 % Injectable SolutionSY07a2b40b-0386-40d4-b0c4-e69e13610cd913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9888-20004049888201 VIAL, MULTI-DOSE in 1 BAG (0404-9888-20) / 20 mL in 1 VIAL, MULTI-DOSE2022-01-122027-03-31NoNoCurrent
0404-9888-50004049888501 VIAL, MULTI-DOSE in 1 BAG (0404-9888-50) / 50 mL in 1 VIAL, MULTI-DOSE2022-01-122027-03-31NoNoCurrent