LIDOCAINE HYDROCHLORIDE

Product NDC
0404-9798
11-digit product format
004049798
Labeler code
0404
Product ID
0404-9798_5ccc5d8a-d811-4889-b772-49874ea26783
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Henry Schein, Inc.
Application
ANDA214336
Marketing category
ANDA
Marketing start
2025-05-27
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
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 HYDROCHLORIDE ANHYDROUS10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
Rxcui1010033

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
0404-9798-50LIDOCAINE HYDROCHLORIDE1 in 1 BAGINJECTION, SOLUTION11
0404-9798-50LIDOCAINE HYDROCHLORIDE50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSNfa7dedcd-d78b-45f2-9dd7-f273043167d01
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDfa7dedcd-d78b-45f2-9dd7-f273043167d01
1010033lidocaine hydrochloride 1 % Injectable SolutionSYfa7dedcd-d78b-45f2-9dd7-f273043167d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0404-9798-50004049798501 VIAL, MULTI-DOSE in 1 BAG (0404-9798-50) / 50 mL in 1 VIAL, MULTI-DOSE2025-05-27NoNoCurrent