FDA.reportPublic FDA data

NA

Product NDC
68055-646
11-digit product format
680550646
Labeler code
68055
Product ID
68055-646_19b2a809-1a5b-472d-98c5-e5e8ef40bb87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION
Labeler
SINTETICA SA
Application
ANDA214267
Marketing category
ANDA
Marketing start
2022-09-19
Marketing end
0000-00-00
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68055-646-01NA5 mL in 1 AMPULEINJECTION, SOLUTION52
68055-646-10NA10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68055-646NA (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [SINTETICA SA]2Legacy NDC, 2 package rows20221004_cb3f71ce-bc8b-4f72-a155-92ab29f23833.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737570lidocaine HCl 1 % in 10 ML InjectionPSNcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737568lidocaine HCl 1 % in 2 ML InjectionPSNcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737566lidocaine HCl 1 % in 5 ML InjectionPSNcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737763lidocaine HCl 2 % in 10 ML InjectionPSNcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737757lidocaine HCl 2 % in 2 ML InjectionPSNcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737761lidocaine HCl 2 % in 5 ML InjectionPSNcb3f71ce-bc8b-4f72-a155-92ab29f238332
173757010 ML lidocaine hydrochloride 10 MG/ML InjectionSCDcb3f71ce-bc8b-4f72-a155-92ab29f238332
173776310 ML lidocaine hydrochloride 20 MG/ML InjectionSCDcb3f71ce-bc8b-4f72-a155-92ab29f238332
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCDcb3f71ce-bc8b-4f72-a155-92ab29f238332
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCDcb3f71ce-bc8b-4f72-a155-92ab29f238332
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDcb3f71ce-bc8b-4f72-a155-92ab29f238332
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCDcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737570lidocaine HCl 1 % in 10 ML InjectionSYcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737568lidocaine HCl 1 % per 2 ML InjectionSYcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737566lidocaine HCl 1 % per 5 ML InjectionSYcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737570lidocaine HCl 100 MG per 10 ML InjectionSYcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737761lidocaine HCl 100 MG per 5 ML InjectionSYcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737763lidocaine HCl 2 % per 10 ML InjectionSYcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737757lidocaine HCl 2 % per 2 ML InjectionSYcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737761lidocaine HCl 2 % per 5 ML InjectionSYcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737568lidocaine HCl 20 MG per 2 ML InjectionSYcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737763lidocaine HCl 200 MG per 10 ML InjectionSYcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737757lidocaine HCl 40 MG per 2 ML InjectionSYcb3f71ce-bc8b-4f72-a155-92ab29f238332
1737566lidocaine HCl 50 MG per 5 ML InjectionSYcb3f71ce-bc8b-4f72-a155-92ab29f238332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68055-646-01680550646015 mL in 1 AMPULE5 mlHistorical
68055-646-106805506461010 AMPULE in 1 CARTON (68055-646-10) > 5 mL in 1 AMPULE (68055-646-01) 10 ampule2022-09-190000-00-00NoNoCurrent