FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
76420-080
11-digit product format
764200080
Labeler code
76420
Product ID
76420-080_a2dc0a04-7bb0-b275-e053-2995a90a1004
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Asclemed USA, Inc.
Application
ANDA203082
Marketing category
ANDA
Marketing start
2013-03-14
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
Rxcui1737566

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
76420-080-05Lidocaine Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-080-05ML - Milliliter76420-08027830bb5-b200-44f9-bf7d-54235c469ce912020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-080LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 1 package rows20200410_b8803e38-fe30-48ec-9399-013f2880e0eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737566lidocaine HCl 1 % in 5 ML InjectionPSNb8803e38-fe30-48ec-9399-013f2880e0eb1
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDb8803e38-fe30-48ec-9399-013f2880e0eb1
1737566lidocaine HCl 1 % per 5 ML InjectionSYb8803e38-fe30-48ec-9399-013f2880e0eb1
1737566lidocaine HCl 50 MG per 5 ML InjectionSYb8803e38-fe30-48ec-9399-013f2880e0eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-080-05764200080055 mL in 1 VIAL, SINGLE-DOSE (76420-080-05) 5 ml2020-04-090000-00-00NoNoCurrent