Lidocaine Hydrochloride

Product NDC
52584-013
11-digit product format
525840013
Labeler code
52584
Product ID
52584-013_690f91ba-c99a-4b1e-a1cd-334e36a9cbc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
JELLY
Route
TOPICAL
Labeler
General Injectables & Vaccines, Inc
Application
ANDA086283
Marketing category
ANDA
Marketing start
2010-09-01
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
52584-013-002020-01-31C16284748780-19d75b9d0-701e-f424-e053-dadaa90a57ceLidocaine HCL Jelly, USP, 2% 20 mg/mL 10 mL Sterile Pak Uro-Jet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52584-013-00Lidocaine Hydrochloride20 mL in 1 VIAL, SINGLE-USEJELLY204
52584-013-00Lidocaine Hydrochloride1 in 1 BAGJELLY14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52584-013LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE) JELLY [GENERAL INJECTABLES & VACCINES, INC]4Legacy NDC, 2 package rows20170112_fa8f924b-bc1d-4864-923b-b1d4234504cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSNfa8f924b-bc1d-4864-923b-b1d4234504cd4
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDfa8f924b-bc1d-4864-923b-b1d4234504cd4
1011852lidocaine hydrochloride 2 % Topical JellySYfa8f924b-bc1d-4864-923b-b1d4234504cd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52584-013-005258400130020 mL in 1 VIAL, SINGLE-USE20 mlHistorical