FDA.reportPublic FDA data

LIDOCAINE

Product NDC
62332-424
11-digit product format
623320424
Labeler code
62332
Product ID
62332-424_cff70a7e-cf8a-4700-8c55-23dd4fe8ae71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA211469
Marketing category
ANDA
Marketing start
2018-11-30
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

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
62332-424-30LIDOCAINE30 g in 1 TUBEOINTMENT3012
62332-424-30LIDOCAINE1 in 1 CARTONOINTMENT112
62332-424-35LIDOCAINE1 in 1 CARTONOINTMENT112
62332-424-35LIDOCAINE35.44 g in 1 TUBEOINTMENT35.4412
62332-424-50LIDOCAINE50 g in 1 JAROINTMENT5012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-424-30GM - Gram62332-424366b8b04-e6b2-4212-98ac-f51cd0c4319512019-04-11
62332-424-35GM - Gram62332-424e48a845d-66af-4d63-9dcd-139a7604215112019-04-11
62332-424-50GM - Gram62332-4248ce71743-d92b-4696-80c0-93912cbb327e12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-424LIDOCAINE OINTMENT [ALEMBIC PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 5 package rows20231031_11a8b27a-1e25-46e5-bc23-ae5c894b4da4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN11a8b27a-1e25-46e5-bc23-ae5c894b4da412
1543069lidocaine 0.05 MG/MG Topical OintmentSCD11a8b27a-1e25-46e5-bc23-ae5c894b4da412
1543069lidocaine 5 % Topical OintmentSY11a8b27a-1e25-46e5-bc23-ae5c894b4da412
1543069lidocaine 5 % Topical OintmentPSNe7ed90d7-11c0-4781-a727-1fe3659a29485
1543069lidocaine 0.05 MG/MG Topical OintmentSCDe7ed90d7-11c0-4781-a727-1fe3659a29485
1543069lidocaine 5 % Topical OintmentSYe7ed90d7-11c0-4781-a727-1fe3659a29485
1543069lidocaine 5 % Topical OintmentPSN38f31902-99fd-4a63-853e-b5f93dfc59804
1543069lidocaine 0.05 MG/MG Topical OintmentSCD38f31902-99fd-4a63-853e-b5f93dfc59804
1543069lidocaine 5 % Topical OintmentSY38f31902-99fd-4a63-853e-b5f93dfc59804
1543069lidocaine 5 % Topical OintmentPSNc98eeb63-c896-4417-b0ad-66c4a87efeee3
1543069lidocaine 0.05 MG/MG Topical OintmentSCDc98eeb63-c896-4417-b0ad-66c4a87efeee3
1543069lidocaine 5 % Topical OintmentSYc98eeb63-c896-4417-b0ad-66c4a87efeee3
1543069lidocaine 5 % Topical OintmentPSNdfef4554-aeb4-4bdf-9557-648d3e84af3c2
1543069lidocaine 0.05 MG/MG Topical OintmentSCDdfef4554-aeb4-4bdf-9557-648d3e84af3c2
1543069lidocaine 5 % Topical OintmentSYdfef4554-aeb4-4bdf-9557-648d3e84af3c2
1543069lidocaine 5 % Topical OintmentPSN259f3f4b-50d0-066c-e063-6394a90a2a1e1
1543069lidocaine 5 % Topical OintmentPSN3a63652c-92a1-612b-e063-6294a90a034a1
1543069lidocaine 0.05 MG/MG Topical OintmentSCD3a63652c-92a1-612b-e063-6294a90a034a1
1543069lidocaine 0.05 MG/MG Topical OintmentSCD259f3f4b-50d0-066c-e063-6394a90a2a1e1
1543069lidocaine 5 % Topical OintmentSY3a63652c-92a1-612b-e063-6294a90a034a1
1543069lidocaine 5 % Topical OintmentSY259f3f4b-50d0-066c-e063-6394a90a2a1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-424-30623320424301 TUBE in 1 CARTON (62332-424-30) / 30 g in 1 TUBE1 tube2018-11-300000-00-00NoNoCurrent
62332-424-35623320424351 TUBE in 1 CARTON (62332-424-35) / 35.44 g in 1 TUBE1 tube2018-11-300000-00-00NoNoCurrent
62332-424-506233204245050 g in 1 JAR (62332-424-50) 50 g2018-11-300000-00-00NoNoCurrent