FDA.reportPublic FDA data

Lidocaine hydrochloride

Product NDC
72888-125
11-digit product format
728880125
Labeler code
72888
Product ID
72888-125_4b1eaa83-b1d8-36f6-e063-6294a90a367c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine hydrochloride
Dosage form
SOLUTION
Route
ORAL; TOPICAL
Labeler
Advagen Pharma Ltd
Application
ANDA216780
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
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
72888-125-26Lidocaine hydrochloride100 mL in 1 BOTTLESOLUTION1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-125-26ML - Milliliter72888-125a01d81a8-d0c1-45b4-a42f-55040ddb000312023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-125LIDOCAINE HYDROCHLORIDE SOLUTION [ADVAGEN PHARMA LTD]3Current NDC, 1 package rows20250328_ae40021b-8df8-4b16-aac0-dcec88f76c7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSNae40021b-8df8-4b16-aac0-dcec88f76c7d5
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCDae40021b-8df8-4b16-aac0-dcec88f76c7d5
1010739lidocaine HCl 2 % Oral Topical SolutionSYae40021b-8df8-4b16-aac0-dcec88f76c7d5
1010739lidocaine HCl 2 % Oromucosal SolutionSYae40021b-8df8-4b16-aac0-dcec88f76c7d5
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSNe67dee40-b243-4d6b-bc6b-e52c6cb798b84
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSNadc4dd69-45f3-48fe-bf85-f014b384c38e4
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN55aa77b8-7601-4432-8631-bfec58daf2474
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCDadc4dd69-45f3-48fe-bf85-f014b384c38e4
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCDe67dee40-b243-4d6b-bc6b-e52c6cb798b84
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD55aa77b8-7601-4432-8631-bfec58daf2474
1010739lidocaine HCl 2 % Oral Topical SolutionSYe67dee40-b243-4d6b-bc6b-e52c6cb798b84
1010739lidocaine HCl 2 % Oral Topical SolutionSYadc4dd69-45f3-48fe-bf85-f014b384c38e4
1010739lidocaine HCl 2 % Oral Topical SolutionSY55aa77b8-7601-4432-8631-bfec58daf2474
1010739lidocaine HCl 2 % Oromucosal SolutionSYe67dee40-b243-4d6b-bc6b-e52c6cb798b84
1010739lidocaine HCl 2 % Oromucosal SolutionSY55aa77b8-7601-4432-8631-bfec58daf2474
1010739lidocaine HCl 2 % Oromucosal SolutionSYadc4dd69-45f3-48fe-bf85-f014b384c38e4
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN75d17334-6876-42d0-8a02-82669d139e4f3
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD75d17334-6876-42d0-8a02-82669d139e4f3
1010739lidocaine HCl 2 % Oral Topical SolutionSY75d17334-6876-42d0-8a02-82669d139e4f3
1010739lidocaine HCl 2 % Oromucosal SolutionSY75d17334-6876-42d0-8a02-82669d139e4f3
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN037764d3-da0e-5ebb-e063-6294a90ab6e02
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD037764d3-da0e-5ebb-e063-6294a90ab6e02
1010739lidocaine HCl 2 % Oral Topical SolutionSY037764d3-da0e-5ebb-e063-6294a90ab6e02
1010739lidocaine HCl 2 % Oromucosal SolutionSY037764d3-da0e-5ebb-e063-6294a90ab6e02
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN401ecb6c-392b-1d74-e063-6294a90a40051
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN0a36a6de-40d5-41ba-bb5f-39d36c267b7f1
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD401ecb6c-392b-1d74-e063-6294a90a40051
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD0a36a6de-40d5-41ba-bb5f-39d36c267b7f1
1010739lidocaine HCl 2 % Oral Topical SolutionSY401ecb6c-392b-1d74-e063-6294a90a40051
1010739lidocaine HCl 2 % Oral Topical SolutionSY0a36a6de-40d5-41ba-bb5f-39d36c267b7f1
1010739lidocaine HCl 2 % Oromucosal SolutionSY401ecb6c-392b-1d74-e063-6294a90a40051
1010739lidocaine HCl 2 % Oromucosal SolutionSY0a36a6de-40d5-41ba-bb5f-39d36c267b7f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-125-2672888012526100 mL in 1 BOTTLE (72888-125-26) 100 ml2023-03-28NoNoHistorical