FDA.reportPublic FDA data

Lidocaine

Product NDC
64380-789
11-digit product format
643800789
Labeler code
64380
Product ID
64380-789_e6c9429c-13b9-4932-abad-e605c4c7fb68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Strides Pharma Science Limited
Application
ANDA210958
Marketing category
ANDA
Marketing start
2019-01-01
Substance
LIDOCAINE
Active strength
50 mg/g
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1543069

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
64380-789-23Lidocaine30 g in 1 TUBEOINTMENT304
64380-789-32Lidocaine35.44 g in 1 TUBEOINTMENT35.444
64380-789-33Lidocaine50 g in 1 JAROINTMENT504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-789-23GM - Gram64380-789cabe49b8-d14a-419d-bc87-d7c785ddee0d12019-08-06
64380-789-32GM - Gram64380-789f842f254-c43e-4a45-9ba0-6c21fdc75a2312019-08-06
64380-789-33GM - Gram64380-789d00b6f01-38fe-4a38-b951-43513e782ba112020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-789LIDOCAINE OINTMENT [STRIDES PHARMA SCIENCE LIMITED]4Current NDC, Legacy NDC, 3 package rows20190101_8b1efeaa-31b1-4f34-960f-7a920ac07355.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN8b1efeaa-31b1-4f34-960f-7a920ac073554
1543069lidocaine 0.05 MG/MG Topical OintmentSCD8b1efeaa-31b1-4f34-960f-7a920ac073554
1543069lidocaine 5 % Topical OintmentSY8b1efeaa-31b1-4f34-960f-7a920ac073554
1543069lidocaine 5 % Topical OintmentPSNfeb8692a-9c08-0d5c-e053-6394a90a904b2
1543069lidocaine 0.05 MG/MG Topical OintmentSCDfeb8692a-9c08-0d5c-e053-6394a90a904b2
1543069lidocaine 5 % Topical OintmentSYfeb8692a-9c08-0d5c-e053-6394a90a904b2
1543069lidocaine 5 % Topical OintmentPSN2718a56f-345f-4d88-82d2-364e0f155d971
1543069lidocaine 5 % Topical OintmentPSN2b9150ea-a876-4511-8d5b-aa72507ef8631
1543069lidocaine 5 % Topical OintmentPSN5e05fbdf-3495-48e5-bdf4-188c069dd1f81
1543069lidocaine 0.05 MG/MG Topical OintmentSCD2718a56f-345f-4d88-82d2-364e0f155d971
1543069lidocaine 0.05 MG/MG Topical OintmentSCD2b9150ea-a876-4511-8d5b-aa72507ef8631
1543069lidocaine 0.05 MG/MG Topical OintmentSCD5e05fbdf-3495-48e5-bdf4-188c069dd1f81
1543069lidocaine 5 % Topical OintmentSY2718a56f-345f-4d88-82d2-364e0f155d971
1543069lidocaine 5 % Topical OintmentSY2b9150ea-a876-4511-8d5b-aa72507ef8631
1543069lidocaine 5 % Topical OintmentSY5e05fbdf-3495-48e5-bdf4-188c069dd1f81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-789-236438007892330 g in 1 TUBE (64380-789-23) 30 g2019-01-010000-00-00NoNoCurrent
64380-789-326438007893235.44 g in 1 TUBE (64380-789-32) 35.44 g2019-01-010000-00-00NoNoCurrent
64380-789-336438007893350 g in 1 JAR (64380-789-33) 50 g2019-01-010000-00-00NoNoCurrent