FDA.reportPublic FDA data

Lidocaine hydrochloride

Product NDC
0116-4027
11-digit product format
001164027
Labeler code
0116
Product ID
0116-4027_40339386-f6df-fbd0-e063-6294a90a4059
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine hydrochloride
Dosage form
SOLUTION
Route
ORAL; TOPICAL
Labeler
Xttrium Laboratories, Inc.
Application
ANDA087872
Marketing category
ANDA
Marketing start
2023-03-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010739

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0116-4027-10Lidocaine hydrochloride100 mL in 1 BOTTLE, PLASTICSOLUTION1001
0116-4027-15Lidocaine hydrochloride15 mL in 1 CUP, UNIT-DOSESOLUTION151
0116-4027-40Lidocaine hydrochloride10 in 1 TRAYSOLUTION101
0116-4027-40Lidocaine hydrochloride4 in 1 CASESOLUTION41

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN40339593-1142-53ef-e063-6394a90afd4f1
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD40339593-1142-53ef-e063-6394a90afd4f1
1010739lidocaine HCl 2 % Oral Topical SolutionSY40339593-1142-53ef-e063-6394a90afd4f1
1010739lidocaine HCl 2 % Oromucosal SolutionSY40339593-1142-53ef-e063-6394a90afd4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0116-4027-1000116402710100 mL in 1 BOTTLE, PLASTIC (0116-4027-10) 100 ml2025-10-15NoNoHistorical
0116-4027-150011640271515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
0116-4027-40001164027404 TRAY in 1 CASE (0116-4027-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0116-4027-15) 4 tray2025-10-15NoNoHistorical