XYLOCAIN (LIDOCAINE HCl )

Product NDC
51662-1587
11-digit product format
516621587
Labeler code
51662
Product ID
51662-1587_3491e60a-3f41-0641-e063-6294a90a8cbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
XYLOCAINE (LIDOCAINE HCl )
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA006488
Marketing category
NDA
Marketing start
2022-06-15
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
XYLOCAIN (LIDOCAINE HCl )
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
Rxcui1010033, 1010035

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
51662-1587-1XYLOCAIN (LIDOCAINE HCl )50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION504
51662-1587-2XYLOCAIN (LIDOCAINE HCl )1 in 1 POUCHINJECTION, SOLUTION14
51662-1587-3XYLOCAIN (LIDOCAINE HCl )25 in 1 CASEINJECTION, SOLUTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1587XYLOCAIN (LIDOCAINE HCL ) (XYLOCAINE (LIDOCAINE HCL )) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Current NDC, Legacy NDC, 3 package rows20250509_e1838a93-7f2a-14f1-e053-2a95a90a8d69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSNe1838a93-7f2a-14f1-e053-2a95a90a8d694
1010035Xylocaine 1 % Injectable SolutionPSNe1838a93-7f2a-14f1-e053-2a95a90a8d694
1010035lidocaine hydrochloride 10 MG/ML Injectable Solution [Xylocaine]SBDe1838a93-7f2a-14f1-e053-2a95a90a8d694
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDe1838a93-7f2a-14f1-e053-2a95a90a8d694
1010033lidocaine hydrochloride 1 % Injectable SolutionSYe1838a93-7f2a-14f1-e053-2a95a90a8d694
1010035Xylocaine 1 % Injectable SolutionSYe1838a93-7f2a-14f1-e053-2a95a90a8d694
1010035Xylocaine 10 MG/ML Injectable SolutionSYe1838a93-7f2a-14f1-e053-2a95a90a8d694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1587-15166215870150 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
51662-1587-2516621587021 in 1 POUCHHistorical
51662-1587-35166215870325 POUCH in 1 CASE (51662-1587-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1587-2) / 50 mL in 1 VIAL, MULTI-DOSE (51662-1587-1) 25 pouch2022-06-150000-00-00NoNoCurrent