FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
0404-9898
11-digit product format
004049898
Labeler code
0404
Product ID
0404-9898_cc325cee-bf3f-4254-80ef-c74534f0dda7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
JELLY
Route
TOPICAL
Labeler
Henry Schein, Inc.
Application
ANDA086283
Marketing category
ANDA
Marketing start
2022-01-12
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
Rxcui1011852

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
0404-9898-10Lidocaine Hydrochloride10 mL in 1 VIAL, SINGLE-USEJELLY105
0404-9898-10Lidocaine Hydrochloride1 in 1 BAGJELLY15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9898LIDOCAINE HYDROCHLORIDE JELLY [HENRY SCHEIN, INC.]4Current NDC, Legacy NDC, 2 package rows20240926_f0617ab8-555f-4cbe-9795-c922f5ef176e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSNf0617ab8-555f-4cbe-9795-c922f5ef176e5
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDf0617ab8-555f-4cbe-9795-c922f5ef176e5
1011852lidocaine hydrochloride 2 % Topical JellySYf0617ab8-555f-4cbe-9795-c922f5ef176e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9898-10004049898101 VIAL, SINGLE-USE in 1 BAG (0404-9898-10) / 10 mL in 1 VIAL, SINGLE-USE2022-01-120000-00-00NoNoCurrent