FDA.reportPublic FDA data

Lidocaine

Product NDC
0143-9172
11-digit product format
001439172
Labeler code
0143
Product ID
0143-9172_e9b92d4d-8944-4235-8d77-3218f82f00a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA080407
Marketing category
ANDA
Marketing start
2025-05-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine
Listing expiration
2027-12-31

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
0143-9172-01Lidocaine20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION206
0143-9172-10Lidocaine10 in 1 CARTONINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9172-01ML - Milliliter0143-91727b72ea1e-efec-4df1-95b8-d49d8f01895712025-06-13
0143-9172-10ML - Milliliter0143-9172305cf303-b36f-4e3c-8c47-84127529fe0e12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9172LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, 2 package rows20250521_5523fdfe-69fd-49a5-b51f-73e2223d49a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSN5523fdfe-69fd-49a5-b51f-73e2223d49a96
1010671lidocaine HCl 2 % Injectable SolutionPSN5523fdfe-69fd-49a5-b51f-73e2223d49a96
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD5523fdfe-69fd-49a5-b51f-73e2223d49a96
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD5523fdfe-69fd-49a5-b51f-73e2223d49a96
1010033lidocaine hydrochloride 1 % Injectable SolutionSY5523fdfe-69fd-49a5-b51f-73e2223d49a96
1010671lidocaine hydrochloride 2 % Injectable SolutionSY5523fdfe-69fd-49a5-b51f-73e2223d49a96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9172-010014391720120 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
0143-9172-100014391721010 VIAL, MULTI-DOSE in 1 CARTON (0143-9172-10) / 20 mL in 1 VIAL, MULTI-DOSE (0143-9172-01) 2025-05-20NoNoHistorical