FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
65282-1605
11-digit product format
652821605
Labeler code
65282
Product ID
65282-1605_447bfde4-fff3-32a6-e063-6394a90a667e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Spectra Medical Devices, LLC
Application
ANDA208017
Marketing category
ANDA
Marketing start
2018-04-18
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
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 HYDROCHLORIDE ANHYDROUS10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
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
65282-1605-1Lidocaine Hydrochloride5 mL in 1 AMPULEINJECTION, SOLUTION517
65282-1605-1Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION2517

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65282-1605LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE ANHYDROUS) INJECTION, SOLUTION [SPECTRA MEDICAL DEVICES, LLC]16Current NDC, Legacy NDC, 2 package rows20240113_e8ba012a-08a9-4f67-9f88-3284377e80be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737566lidocaine HCl 1 % in 5 ML InjectionPSNe8ba012a-08a9-4f67-9f88-3284377e80be17
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDe8ba012a-08a9-4f67-9f88-3284377e80be17
1737566lidocaine HCl 1 % per 5 ML InjectionSYe8ba012a-08a9-4f67-9f88-3284377e80be17
1737566lidocaine HCl 50 MG per 5 ML InjectionSYe8ba012a-08a9-4f67-9f88-3284377e80be17
1737566lidocaine HCl 1 % in 5 ML InjectionPSNdef640dd-bce2-4c18-9ee1-4a1cd5852e891
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDdef640dd-bce2-4c18-9ee1-4a1cd5852e891
1737566lidocaine HCl 1 % per 5 ML InjectionSYdef640dd-bce2-4c18-9ee1-4a1cd5852e891
1737566lidocaine HCl 50 MG per 5 ML InjectionSYdef640dd-bce2-4c18-9ee1-4a1cd5852e891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65282-1605-16528216050125 AMPULE in 1 CARTON (65282-1605-1) / 5 mL in 1 AMPULE25 ampule2018-04-180000-00-00NoNoCurrent