FDA.reportPublic FDA data

LIDOCAINE HYDROCHLORIDE

Product NDC
0404-9885
11-digit product format
004049885
Labeler code
0404
Product ID
0404-9885_14e28ba3-c03b-4664-a06e-d3ceb65c12fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA088328
Marketing category
ANDA
Marketing start
2022-01-11
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1737343

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
0404-9885-50LIDOCAINE HYDROCHLORIDE50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION506
0404-9885-50LIDOCAINE HYDROCHLORIDE1 in 1 BAGINJECTION, SOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9885LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 2 package rows20240608_ee21518e-b3ed-405a-ac3b-bfe753893dba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737343lidocaine HCl 0.5 % in 50 ML InjectionPSNee21518e-b3ed-405a-ac3b-bfe753893dba6
173734350 ML lidocaine hydrochloride 5 MG/ML InjectionSCDee21518e-b3ed-405a-ac3b-bfe753893dba6
1737343lidocaine HCl 0.5 % per 50 ML InjectionSYee21518e-b3ed-405a-ac3b-bfe753893dba6
1737343lidocaine HCl 250 MG per 50 ML InjectionSYee21518e-b3ed-405a-ac3b-bfe753893dba6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9885-50004049885501 VIAL, SINGLE-DOSE in 1 BAG (0404-9885-50) / 50 mL in 1 VIAL, SINGLE-DOSE2022-01-110000-00-00NoNoCurrent