Xylocaine

Product NDC
50090-3321
11-digit product format
500903321
Labeler code
50090
Product ID
50090-3321_ed286913-c52d-42f2-9343-568526467f3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
A-S Medication Solutions
Application
NDA006488
Marketing category
NDA
Marketing start
2010-08-12
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
Active strength
20 mg/mL; mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3321-12023-01-30C16284748780-1f386c649-bc32-0266-e053-dadaa90a7c1aXylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3321-1XylocaineMPF20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3321-1ML - Milliliter50090-3321acfdaec0-16ab-49c3-b1b8-889615b2b3b912021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3321XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20191012_307e29b4-bcc1-4393-ab72-0687843bd1e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010688lidocaine HCl 2 % / EPINEPHrine 1:200,000 in 20 ML InjectionPSN307e29b4-bcc1-4393-ab72-0687843bd1e32
1010692Xylocaine 2 % / EPINEPHrine 1:200,000 in 20 ML InjectionPSN307e29b4-bcc1-4393-ab72-0687843bd1e32
101069220 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML Injection [Xylocaine with Epinephrine]SBD307e29b4-bcc1-4393-ab72-0687843bd1e32
101068820 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML InjectionSCD307e29b4-bcc1-4393-ab72-0687843bd1e32
1010688lidocaine HCl 2 % / EPINEPHrine 1:200,000 per 20 ML InjectionSY307e29b4-bcc1-4393-ab72-0687843bd1e32
1010692Xylocaine 2 % / EPINEPHrine 1:200,000 per 20 ML InjectionSY307e29b4-bcc1-4393-ab72-0687843bd1e32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3321-15009033210120 mL in 1 VIAL, SINGLE-DOSE (50090-3321-1) 20 ml2019-09-230000-00-00NoNoCurrent