FDA.reportPublic FDA data

2% LIDOCAINE HCI

Product NDC
51662-1231
11-digit product format
516621231
Labeler code
51662
Product ID
51662-1231_132cd630-c24a-448d-e063-6294a90a33f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
2% LIDOCAINE HCI
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co. LLC, DBA Health First
Application
ANDA083158
Marketing category
ANDA
Marketing start
2018-08-25
Substance
LIDOCAINE HYDROCHLORIDE
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
2% LIDOCAINE HCI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1012068

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
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
51662-1231-12020-02-07C16284748780-19d75b9d0-bad3-f424-e053-dadaa90a57ce2% LIDOCAINE HCI INJ., USP 100mg/5mL SYR
51662-1231-12020-01-31C16284748780-19d75b9d0-bad3-f424-e053-dadaa90a57ce2% LIDOCAINE HCI INJ., USP 100mg/5mL SYR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1231-12% LIDOCAINE HCI5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION57
51662-1231-12% LIDOCAINE HCI1 in 1 CARTONINJECTION, SOLUTION17
51662-1231-22% LIDOCAINE HCI1 in 1 CARTONINJECTION, SOLUTION17
51662-1231-22% LIDOCAINE HCI1 in 1 POUCHINJECTION, SOLUTION17
51662-1231-32% LIDOCAINE HCI10 in 1 CASEINJECTION, SOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-12312% LIDOCAINE HCI INJECTION, SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTH FIRST]7Current NDC, Legacy NDC, 5 package rows20240310_74450548-62f4-b77f-e053-2991aa0ae5cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012068lidocaine HCl 2 % in 5 ML Prefilled SyringePSN74450548-62f4-b77f-e053-2991aa0ae5cf7
10120685 ML lidocaine hydrochloride 20 MG/ML Prefilled SyringeSCD74450548-62f4-b77f-e053-2991aa0ae5cf7
1012068lidocaine HCl 100 MG per 5 ML Prefilled SyringeSY74450548-62f4-b77f-e053-2991aa0ae5cf7
1012068lidocaine HCl 2 % per 5 ML Prefilled SyringeSY74450548-62f4-b77f-e053-2991aa0ae5cf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1231-1516621231011 SYRINGE, PLASTIC in 1 CARTON (51662-1231-1) / 5 mL in 1 SYRINGE, PLASTIC2018-08-250000-00-00NoNoCurrent
51662-1231-2516621231021 in 1 CARTONHistorical
51662-1231-35166212310310 POUCH in 1 CASE (51662-1231-3) / 1 CARTON in 1 POUCH (51662-1231-2) / 1 SYRINGE in 1 CARTON / 5 mL in 1 SYRINGE10 pouch2023-03-24NoNoCurrent