FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
0121-0972
11-digit product format
001210972
Labeler code
0121
Product ID
0121-0972_498bed31-acd1-4f21-bb38-65ee6db6c573
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA204494
Marketing category
ANDA
Marketing start
2023-07-31
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010878

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
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
0121-0972-51Lidocaine Hydrochloride1 in 1 CARTONSOLUTION18
0121-0972-51Lidocaine Hydrochloride50 mL in 1 BOTTLE, GLASSSOLUTION508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0972-51ML - Milliliter0121-09722204d837-ff6d-4ad4-86f7-b0b8a983ff3712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0972LIDOCAINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]5Current NDC, 2 package rows20241116_9920daef-b156-4a14-b641-f714191ffb5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010878lidocaine HCl 4 % Mucous Membrane Topical SolutionPSN9920daef-b156-4a14-b641-f714191ffb5c8
1010878lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical SolutionSCD9920daef-b156-4a14-b641-f714191ffb5c8
1010878lidocaine hydrochloride 4 % Mucous Membrane Topical SolutionSY9920daef-b156-4a14-b641-f714191ffb5c8
1010878lidocaine hydrochloride 4 % Oromucosal SolutionSY9920daef-b156-4a14-b641-f714191ffb5c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0121-0972-51001210972511 BOTTLE, GLASS in 1 CARTON (0121-0972-51) / 50 mL in 1 BOTTLE, GLASS2023-07-31NoNoCurrent