FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
52565-009
11-digit product format
525650009
Labeler code
52565
Product ID
52565-009_67386546-40ad-4093-90fb-8a7ae41eb0c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA204494
Marketing category
ANDA
Marketing start
2014-03-18
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
40 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
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
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
52565-009-502023-01-30C16284748780-1f386c64a-096e-0266-e053-dadaa90a7c1aLidocaine Hydrochloride Topical Solution USP, 4% Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-009-50Lidocaine Hydrochloride1 in 1 CARTONSOLUTION15
52565-009-50Lidocaine Hydrochloride50 mL in 1 BOTTLE, GLASSSOLUTION505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-009-50ML - Milliliter52565-009f1458096-d9e8-4b55-a389-f0c16ecfa29112014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE SOLUTION [IGI LABS, INC.]2
LidocaineACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [IGI LABS, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE SOLUTION [IGI LABS, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE SOLUTION [IGI LABS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE SOLUTION [IGI LABS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-009LIDOCAINE HYDROCHLORIDE SOLUTION [TELIGENT PHARMA, INC.]5Legacy NDC, 2 package rows20191217_b9ecc644-1c3f-46c5-91ec-d310884393bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010878lidocaine HCl 4 % Mucous Membrane Topical SolutionPSNb9ecc644-1c3f-46c5-91ec-d310884393bd5
1010878lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical SolutionSCDb9ecc644-1c3f-46c5-91ec-d310884393bd5
1010878lidocaine hydrochloride 4 % Mucous Membrane Topical SolutionSYb9ecc644-1c3f-46c5-91ec-d310884393bd5
1010878lidocaine hydrochloride 4 % Oromucosal SolutionSYb9ecc644-1c3f-46c5-91ec-d310884393bd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52565-009-50525650009501 BOTTLE, GLASS in 1 CARTON (52565-009-50) > 50 mL in 1 BOTTLE, GLASS2014-03-180000-00-00NoNoCurrent