FDA.reportPublic FDA data

lidocaine

Product NDC
68462-418
11-digit product format
684620418
Labeler code
68462
Product ID
68462-418_e7d81e46-e9d0-42ff-bcf8-ec4828368bea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA206498
Marketing category
ANDA
Marketing start
2016-07-01
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
68462-418-20lidocaine35.44 g in 1 TUBEOINTMENT35.446
68462-418-20lidocaine1 in 1 CARTONOINTMENT16
68462-418-27lidocaine50 g in 1 JAROINTMENT506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-418-20GM - Gram68462-418252f8c9b-5763-40a6-809f-3da03b4330f912016-10-06
68462-418-27GM - Gram68462-418b5ef5a36-7293-42e9-add3-0e8c617d8e1a12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-418LIDOCAINE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]6Current NDC, Legacy NDC, 3 package rows20240104_eaa15be7-11ea-49bc-ac07-739075453be6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN4704b33c-19bf-47d0-abf7-e1fbaa1518a57
1543069lidocaine 0.05 MG/MG Topical OintmentSCD4704b33c-19bf-47d0-abf7-e1fbaa1518a57
1543069lidocaine 5 % Topical OintmentSY4704b33c-19bf-47d0-abf7-e1fbaa1518a57
1543069lidocaine 5 % Topical OintmentPSNeaa15be7-11ea-49bc-ac07-739075453be66
1543069lidocaine 0.05 MG/MG Topical OintmentSCDeaa15be7-11ea-49bc-ac07-739075453be66
1543069lidocaine 5 % Topical OintmentSYeaa15be7-11ea-49bc-ac07-739075453be66
1543069lidocaine 5 % Topical OintmentPSN991805d6-e169-46cb-8074-f8b8fb89afd05
1543069lidocaine 0.05 MG/MG Topical OintmentSCD991805d6-e169-46cb-8074-f8b8fb89afd05
1543069lidocaine 5 % Topical OintmentSY991805d6-e169-46cb-8074-f8b8fb89afd05
1543069lidocaine 5 % Topical OintmentPSN54df7353-5411-43ad-bd7b-a3d4d62c72c64
1543069lidocaine 0.05 MG/MG Topical OintmentSCD54df7353-5411-43ad-bd7b-a3d4d62c72c64
1543069lidocaine 5 % Topical OintmentSY54df7353-5411-43ad-bd7b-a3d4d62c72c64
1543069lidocaine 5 % Topical OintmentPSNf9b290d2-0e24-4ca8-bca2-3016f5c404df3
1543069lidocaine 5 % Topical OintmentPSN00725e5b-694c-b9e1-e063-6294a90a41823
1543069lidocaine 5 % Topical OintmentPSN499b4443-7aed-4ac5-ab16-f47e759c32013
1543069lidocaine 0.05 MG/MG Topical OintmentSCDf9b290d2-0e24-4ca8-bca2-3016f5c404df3
1543069lidocaine 0.05 MG/MG Topical OintmentSCD00725e5b-694c-b9e1-e063-6294a90a41823
1543069lidocaine 0.05 MG/MG Topical OintmentSCD499b4443-7aed-4ac5-ab16-f47e759c32013
1543069lidocaine 5 % Topical OintmentSYf9b290d2-0e24-4ca8-bca2-3016f5c404df3
1543069lidocaine 5 % Topical OintmentSY00725e5b-694c-b9e1-e063-6294a90a41823
1543069lidocaine 5 % Topical OintmentSY499b4443-7aed-4ac5-ab16-f47e759c32013
1543069lidocaine 5 % Topical OintmentPSN3a602aee-09e2-892c-e063-6294a90a558f2
1543069lidocaine 0.05 MG/MG Topical OintmentSCD3a602aee-09e2-892c-e063-6294a90a558f2
1543069lidocaine 5 % Topical OintmentSY3a602aee-09e2-892c-e063-6294a90a558f2
1543069lidocaine 5 % Topical OintmentPSN259f7b21-98c7-3b41-e063-6294a90a34fa1
1543069lidocaine 5 % Topical OintmentPSNbc92d8aa-1524-6456-e053-2995a90a1cd31
1543069lidocaine 5 % Topical OintmentPSN9af2a701-6606-1e46-e053-2995a90a070d1
1543069lidocaine 5 % Topical OintmentPSN4134f30d-5cb0-e14b-e063-6394a90a45231
1543069lidocaine 5 % Topical OintmentPSN6abf3773-0e60-48b1-9d5c-adc590363d131
1543069lidocaine 5 % Topical OintmentPSN58c9afe4-dc36-4f71-8e76-8dff63dc35fb1
1543069lidocaine 0.05 MG/MG Topical OintmentSCD4134f30d-5cb0-e14b-e063-6394a90a45231
1543069lidocaine 0.05 MG/MG Topical OintmentSCD9af2a701-6606-1e46-e053-2995a90a070d1
1543069lidocaine 0.05 MG/MG Topical OintmentSCD6abf3773-0e60-48b1-9d5c-adc590363d131
1543069lidocaine 0.05 MG/MG Topical OintmentSCDbc92d8aa-1524-6456-e053-2995a90a1cd31
1543069lidocaine 0.05 MG/MG Topical OintmentSCD259f7b21-98c7-3b41-e063-6294a90a34fa1
1543069lidocaine 0.05 MG/MG Topical OintmentSCD58c9afe4-dc36-4f71-8e76-8dff63dc35fb1
1543069lidocaine 5 % Topical OintmentSY259f7b21-98c7-3b41-e063-6294a90a34fa1
1543069lidocaine 5 % Topical OintmentSYbc92d8aa-1524-6456-e053-2995a90a1cd31
1543069lidocaine 5 % Topical OintmentSY9af2a701-6606-1e46-e053-2995a90a070d1
1543069lidocaine 5 % Topical OintmentSY4134f30d-5cb0-e14b-e063-6394a90a45231
1543069lidocaine 5 % Topical OintmentSY6abf3773-0e60-48b1-9d5c-adc590363d131
1543069lidocaine 5 % Topical OintmentSY58c9afe4-dc36-4f71-8e76-8dff63dc35fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-418-20684620418201 TUBE in 1 CARTON (68462-418-20) / 35.44 g in 1 TUBE1 tube2016-07-010000-00-00NoNoCurrent
68462-418-276846204182750 g in 1 JAR (68462-418-27) 50 g2016-07-010000-00-00NoNoCurrent