FDA.reportPublic FDA data

Lidocaine

Product NDC
51672-3020
11-digit product format
516723020
Labeler code
51672
Product ID
51672-3020_38f756d4-4046-c839-e063-6294a90afb90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA086724
Marketing category
ANDA
Marketing start
2013-03-25
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-3020-2Lidocaine1 in 1 CARTONOINTMENT17
51672-3020-2Lidocaine30 g in 1 TUBEOINTMENT307
51672-3020-9Lidocaine35.44 g in 1 TUBEOINTMENT35.447
51672-3020-9Lidocaine1 in 1 CARTONOINTMENT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-3020-2GM - Gram51672-3020098b8399-43a0-4bbb-ba82-d29edaa6061712013-05-02
51672-3020-9GM - Gram51672-30207f9abdbe-3fb3-495b-aeed-d09640305c6912015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LidocaineACTIVE INGREDIENT98PI200987LIDOCAINE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
LidocaineACTIVE MOIETY98PI200987LIDOCAINE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PLIDOCAINE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQLIDOCAINE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-3020LIDOCAINE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 4 package rows20190201_ae758020-a508-4a2e-8164-e6c324e826a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSNae758020-a508-4a2e-8164-e6c324e826a37
1543069lidocaine 5 % Topical OintmentPSNb8663046-67a4-4858-e053-2a95a90a8aed7
1543069lidocaine 0.05 MG/MG Topical OintmentSCDae758020-a508-4a2e-8164-e6c324e826a37
1543069lidocaine 0.05 MG/MG Topical OintmentSCDb8663046-67a4-4858-e053-2a95a90a8aed7
1543069lidocaine 5 % Topical OintmentSYae758020-a508-4a2e-8164-e6c324e826a37
1543069lidocaine 5 % Topical OintmentSYb8663046-67a4-4858-e053-2a95a90a8aed7
1543069lidocaine 5 % Topical OintmentPSN7df3366d-af01-9352-e053-2991aa0a8cab1
1543069lidocaine 5 % Topical OintmentPSNb82c6c6d-4461-0b49-e053-2995a90af60c1
1543069lidocaine 0.05 MG/MG Topical OintmentSCD7df3366d-af01-9352-e053-2991aa0a8cab1
1543069lidocaine 0.05 MG/MG Topical OintmentSCDb82c6c6d-4461-0b49-e053-2995a90af60c1
1543069lidocaine 5 % Topical OintmentSY7df3366d-af01-9352-e053-2991aa0a8cab1
1543069lidocaine 5 % Topical OintmentSYb82c6c6d-4461-0b49-e053-2995a90af60c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-3020-2516723020021 TUBE in 1 CARTON (51672-3020-2) / 30 g in 1 TUBE1 tube2013-03-250000-00-00NoNoCurrent
51672-3020-9516723020091 TUBE in 1 CARTON (51672-3020-9) / 35.44 g in 1 TUBE1 tube2013-03-250000-00-00NoNoCurrent