FDA.reportPublic FDA data

Lidocaine hydrochloride

Product NDC
80425-0268
11-digit product format
804250268
Labeler code
80425
Product ID
80425-0268_2a9b9724-0254-e829-e063-6394a90a1c07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA203082
Marketing category
ANDA
Marketing start
2023-02-15
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
Rxcui1737562

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
80425-0268-1Lidocaine hydrochloride1 in 1 CARTONINJECTION, SOLUTION12
80425-0268-1Lidocaine hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0268-1ML - Milliliter80425-02687786b5f3-ad71-4874-954d-fbe9554917ef12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0268LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 2 package rows20250102_f4c19cf5-c8b1-5e9f-e053-2995a90aee53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737562lidocaine HCl 1 % in 30 ML InjectionPSNf4c19cf5-c8b1-5e9f-e053-2995a90aee532
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCDf4c19cf5-c8b1-5e9f-e053-2995a90aee532
1737562lidocaine HCl 1 % per 30 ML InjectionSYf4c19cf5-c8b1-5e9f-e053-2995a90aee532
1737562lidocaine HCl 300 MG per 30 ML InjectionSYf4c19cf5-c8b1-5e9f-e053-2995a90aee532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0268-1804250268011 VIAL, SINGLE-DOSE in 1 CARTON (80425-0268-1) / 30 mL in 1 VIAL, SINGLE-DOSE2023-02-15NoNoHistorical