FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
70756-644
11-digit product format
707560644
Labeler code
70756
Product ID
70756-644_82bb7965-0af0-4cb9-b328-e1bad2e1f6e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Lifestar Pharma LLC
Application
ANDA217693
Marketing category
ANDA
Marketing start
2023-09-14
Substance
LIDOCAINE HYDROCHLORIDE
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010033, 1010671

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-644-25Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION256
70756-644-25Lidocaine Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION26
70756-644-82Lidocaine Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION26
70756-644-82Lidocaine Hydrochloride1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-644-25ML - Milliliter70756-644563be0b2-bffc-4643-982f-2c2679f1358612023-12-05
70756-644-82ML - Milliliter70756-64463ef1e4f-00da-466b-a231-7fd0735be7d812023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-644LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [LIFESTAR PHARMA LLC]6Current NDC, 4 package rows20240904_9cb98fb0-5204-4973-8be7-f44ddbfde2ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSN9cb98fb0-5204-4973-8be7-f44ddbfde2ab6
1010671lidocaine HCl 2 % Injectable SolutionPSN9cb98fb0-5204-4973-8be7-f44ddbfde2ab6
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD9cb98fb0-5204-4973-8be7-f44ddbfde2ab6
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD9cb98fb0-5204-4973-8be7-f44ddbfde2ab6
1010033lidocaine hydrochloride 1 % Injectable SolutionSY9cb98fb0-5204-4973-8be7-f44ddbfde2ab6
1010671lidocaine hydrochloride 2 % Injectable SolutionSY9cb98fb0-5204-4973-8be7-f44ddbfde2ab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-644-257075606442525 VIAL in 1 CARTON (70756-644-25) / 2 mL in 1 VIAL25 vial2023-09-14NoNoCurrent
70756-644-82707560644821 VIAL in 1 CARTON (70756-644-82) / 2 mL in 1 VIAL1 vial2023-09-14NoNoCurrent