FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
72603-505
11-digit product format
726030505
Labeler code
72603
Product ID
72603-505_103c8a6c-c0cf-4cff-92d3-920aaeb39802
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
NorthStar RxLLC
Application
ANDA217692
Marketing category
ANDA
Marketing start
2024-05-01
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
Lidocaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1737568, 1737757, 1737761

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
72603-505-01Lidocaine Hydrochloride5 mL in 1 VIALINJECTION, SOLUTION53
72603-505-10Lidocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION103
72603-505-25Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-505-01ML - Milliliter72603-50505348924-ffc1-4ebb-b240-a06b4f549f1512024-07-12
72603-505-10ML - Milliliter72603-505aa9d304f-823e-4a7a-8c83-36bd7d4b374f12024-07-12
72603-505-25ML - Milliliter72603-5055ea7be6b-e950-41de-91b4-1ac1c979411d12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-505LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [NORTHSTAR RXLLC]3Current NDC, 3 package rows20240706_f065e6d2-b47e-433d-a1fb-f0449cd725f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737568lidocaine HCl 1 % in 2 ML InjectionPSNf065e6d2-b47e-433d-a1fb-f0449cd725f13
1737757lidocaine HCl 2 % in 2 ML InjectionPSNf065e6d2-b47e-433d-a1fb-f0449cd725f13
1737761lidocaine HCl 2 % in 5 ML InjectionPSNf065e6d2-b47e-433d-a1fb-f0449cd725f13
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCDf065e6d2-b47e-433d-a1fb-f0449cd725f13
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCDf065e6d2-b47e-433d-a1fb-f0449cd725f13
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCDf065e6d2-b47e-433d-a1fb-f0449cd725f13
1737568lidocaine HCl 1 % per 2 ML InjectionSYf065e6d2-b47e-433d-a1fb-f0449cd725f13
1737761lidocaine HCl 100 MG per 5 ML InjectionSYf065e6d2-b47e-433d-a1fb-f0449cd725f13
1737757lidocaine HCl 2 % per 2 ML InjectionSYf065e6d2-b47e-433d-a1fb-f0449cd725f13
1737761lidocaine HCl 2 % per 5 ML InjectionSYf065e6d2-b47e-433d-a1fb-f0449cd725f13
1737568lidocaine HCl 20 MG per 2 ML InjectionSYf065e6d2-b47e-433d-a1fb-f0449cd725f13
1737757lidocaine HCl 40 MG per 2 ML InjectionSYf065e6d2-b47e-433d-a1fb-f0449cd725f13
1737761lidocaine HCl 2 % in 5 ML InjectionPSN42df73b0-20ee-d1aa-e063-6294a90aa2751
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD42df73b0-20ee-d1aa-e063-6294a90aa2751
1737761lidocaine HCl 100 MG per 5 ML InjectionSY42df73b0-20ee-d1aa-e063-6294a90aa2751
1737761lidocaine HCl 2 % per 5 ML InjectionSY42df73b0-20ee-d1aa-e063-6294a90aa2751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-505-01726030505015 mL in 1 VIAL5 mlHistorical
72603-505-107260305051010 VIAL in 1 CARTON (72603-505-10) / 5 mL in 1 VIAL (72603-505-01) 10 vial2024-05-01NoNoCurrent
72603-505-257260305052525 VIAL in 1 CARTON (72603-505-25) / 5 mL in 1 VIAL (72603-505-01) 25 vial2024-05-01NoNoCurrent