XYLOCAINE

Product NDC
51662-1590
11-digit product format
516621590
Labeler code
51662
Product ID
51662-1590_08669a95-8c7b-9ad0-e063-6394a90adba2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
XYLOCAINE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA006488
Marketing category
NDA
Marketing start
2022-07-13
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1590-32024-07-17C16284748780-11030e365-2797-111a-e063-dadaa90a10e2Xylocaine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1590-1XYLOCAINE50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION505
51662-1590-2XYLOCAINE1 in 1 POUCHINJECTION, SOLUTION15
51662-1590-3XYLOCAINE25 in 1 CASEINJECTION, SOLUTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1590XYLOCAINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]5Current NDC, Legacy NDC, 3 package rows20240719_e3b3b462-8f35-68b8-e053-2995a90a6403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSNe3b3b462-8f35-68b8-e053-2995a90a64035
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDe3b3b462-8f35-68b8-e053-2995a90a64035
1010033lidocaine hydrochloride 1 % Injectable SolutionSYe3b3b462-8f35-68b8-e053-2995a90a64035

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1590-15166215900150 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
51662-1590-2516621590021 in 1 POUCHHistorical
51662-1590-35166215900325 POUCH in 1 CASE (51662-1590-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1590-2) / 50 mL in 1 VIAL, MULTI-DOSE (51662-1590-1) 25 pouch2022-07-130000-00-00NoNoCurrent