Xylocaine

Product NDC
0404-9974
11-digit product format
004049974
Labeler code
0404
Product ID
0404-9974_e1b9282a-86fb-4fe2-8c95-52c85aeb3c6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine HCl
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Henry Schein, Inc.
Application
NDA006488
Marketing category
NDA
Marketing start
2022-01-17
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
20 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
Xylocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
Rxcui1010671, 1010673

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
0404-9974-20Xylocaine20 mL in 1 VIALINJECTION, SOLUTION205
0404-9974-20Xylocaine1 in 1 BAGINJECTION, SOLUTION15
0404-9974-50Xylocaine1 in 1 BAGINJECTION, SOLUTION15
0404-9974-50Xylocaine50 mL in 1 VIALINJECTION, SOLUTION505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9974XYLOCAINE (LIDOCAINE HCL) INJECTION, SOLUTION [HENRY SCHEIN, INC.]4Current NDC, Legacy NDC, 4 package rows20241018_a6019956-a6e0-4988-a870-6aee06c354c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010671lidocaine HCl 2 % Injectable SolutionPSNa6019956-a6e0-4988-a870-6aee06c354c35
1010673Xylocaine 2 % Injectable SolutionPSNa6019956-a6e0-4988-a870-6aee06c354c35
1010673lidocaine hydrochloride 20 MG/ML Injectable Solution [Xylocaine]SBDa6019956-a6e0-4988-a870-6aee06c354c35
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCDa6019956-a6e0-4988-a870-6aee06c354c35
1010671lidocaine hydrochloride 2 % Injectable SolutionSYa6019956-a6e0-4988-a870-6aee06c354c35
1010673Xylocaine 2 % Injectable SolutionSYa6019956-a6e0-4988-a870-6aee06c354c35
1010673Xylocaine 20 MG/ML Injectable SolutionSYa6019956-a6e0-4988-a870-6aee06c354c35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9974-20004049974201 VIAL in 1 BAG (0404-9974-20) / 20 mL in 1 VIAL1 vial2022-01-170000-00-00NoNoCurrent
0404-9974-50004049974501 VIAL in 1 BAG (0404-9974-50) / 50 mL in 1 VIAL1 vial2022-01-170000-00-00NoNoCurrent