Lidocaine Hydrochloride

Product NDC
76420-078
11-digit product format
764200078
Labeler code
76420
Product ID
76420-078_ead2d6e4-62f7-3b3c-e053-2a95a90a4ccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL
Labeler
Asclemed USA, Inc.
Application
ANDA084625
Marketing category
ANDA
Marketing start
1975-06-16
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
Rxcui1737761

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
76420-078-05Lidocaine Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-078LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 1 package rows20221013_fecd1797-7757-4da8-b3a1-24b258634243.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737761lidocaine HCl 2 % in 5 ML InjectionPSNfecd1797-7757-4da8-b3a1-24b2586342432
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCDfecd1797-7757-4da8-b3a1-24b2586342432
1737761lidocaine HCl 100 MG per 5 ML InjectionSYfecd1797-7757-4da8-b3a1-24b2586342432
1737761lidocaine HCl 2 % per 5 ML InjectionSYfecd1797-7757-4da8-b3a1-24b2586342432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-078-05764200078055 mL in 1 VIAL, SINGLE-DOSE (76420-078-05) 5 ml2020-02-110000-00-00NoNoCurrent