FDA.reportPublic FDA data

NA

Product NDC
83090-001
11-digit product format
830900001
Labeler code
83090
Product ID
83090-001_0d18f291-3a92-421e-8841-6be743b1f154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION
Labeler
Sintetica US LLC
Application
ANDA214267
Marketing category
ANDA
Marketing start
2022-11-15
Marketing end
0000-00-00
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
2023-12-31
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
83090-001-102026-01-29C16284748780-149896155-bf71-586f-e063-e6dba90add90LIDOCAINE HYDROCHLORIDE INJECTION, USP 1% LIDOCAINE HYDROCHLORIDE INJECTION, USP 2% For Infiltration and Nerve Block Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83090-001-01NA2 mL in 1 AMPULEINJECTION, SOLUTION21
83090-001-10NA10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83090-001-10ML - Milliliter83090-0016aae6623-3d22-429b-95bd-711e27578c7a12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83090-001NA (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [SINTETICA US LLC]1Legacy NDC, 2 package rows20221217_aa3e688a-308c-4a82-a268-28ccf1677c55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737570lidocaine HCl 1 % in 10 ML InjectionPSNaa3e688a-308c-4a82-a268-28ccf1677c551
1737568lidocaine HCl 1 % in 2 ML InjectionPSNaa3e688a-308c-4a82-a268-28ccf1677c551
1737566lidocaine HCl 1 % in 5 ML InjectionPSNaa3e688a-308c-4a82-a268-28ccf1677c551
1737763lidocaine HCl 2 % in 10 ML InjectionPSNaa3e688a-308c-4a82-a268-28ccf1677c551
1737757lidocaine HCl 2 % in 2 ML InjectionPSNaa3e688a-308c-4a82-a268-28ccf1677c551
1737761lidocaine HCl 2 % in 5 ML InjectionPSNaa3e688a-308c-4a82-a268-28ccf1677c551
173757010 ML lidocaine hydrochloride 10 MG/ML InjectionSCDaa3e688a-308c-4a82-a268-28ccf1677c551
173776310 ML lidocaine hydrochloride 20 MG/ML InjectionSCDaa3e688a-308c-4a82-a268-28ccf1677c551
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCDaa3e688a-308c-4a82-a268-28ccf1677c551
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCDaa3e688a-308c-4a82-a268-28ccf1677c551
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDaa3e688a-308c-4a82-a268-28ccf1677c551
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCDaa3e688a-308c-4a82-a268-28ccf1677c551
1737570lidocaine HCl 1 % in 10 ML InjectionSYaa3e688a-308c-4a82-a268-28ccf1677c551
1737568lidocaine HCl 1 % per 2 ML InjectionSYaa3e688a-308c-4a82-a268-28ccf1677c551
1737566lidocaine HCl 1 % per 5 ML InjectionSYaa3e688a-308c-4a82-a268-28ccf1677c551
1737570lidocaine HCl 100 MG per 10 ML InjectionSYaa3e688a-308c-4a82-a268-28ccf1677c551
1737761lidocaine HCl 100 MG per 5 ML InjectionSYaa3e688a-308c-4a82-a268-28ccf1677c551
1737763lidocaine HCl 2 % per 10 ML InjectionSYaa3e688a-308c-4a82-a268-28ccf1677c551
1737757lidocaine HCl 2 % per 2 ML InjectionSYaa3e688a-308c-4a82-a268-28ccf1677c551
1737761lidocaine HCl 2 % per 5 ML InjectionSYaa3e688a-308c-4a82-a268-28ccf1677c551
1737568lidocaine HCl 20 MG per 2 ML InjectionSYaa3e688a-308c-4a82-a268-28ccf1677c551
1737763lidocaine HCl 200 MG per 10 ML InjectionSYaa3e688a-308c-4a82-a268-28ccf1677c551
1737757lidocaine HCl 40 MG per 2 ML InjectionSYaa3e688a-308c-4a82-a268-28ccf1677c551
1737566lidocaine HCl 50 MG per 5 ML InjectionSYaa3e688a-308c-4a82-a268-28ccf1677c551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83090-001-01830900001012 mL in 1 AMPULE2 mlHistorical
83090-001-108309000011010 AMPULE in 1 CARTON (83090-001-10) > 2 mL in 1 AMPULE (83090-001-01) 10 ampule2022-11-150000-00-00NoNoCurrent