ELIMITE

Product NDC
59651-834
11-digit product format
596510834
Labeler code
59651
Product ID
59651-834_443c0446-ccba-4f52-83ed-4c3163f35807
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
permethrin
Dosage form
CREAM
Route
TOPICAL
Labeler
Aurobindo Pharma Limited
Application
NDA019855
Marketing category
NDA
Marketing start
2024-01-22
Substance
PERMETHRIN
Active strength
50 mg/g
Pharmacologic classes
Pyrethrins [CS], Pyrethroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ELIMITE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERMETHRIN50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii509F88P9SZ
Rxcui106387, 207485

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f33e3e13-1328-47a9-3012-134a14fcb6a1Product name220190703

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-834-60ELIMITE1 in 1 CARTONCREAM11
59651-834-60ELIMITE60 g in 1 TUBECREAM601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-834-60GM - Gram59651-8342a6517f4-1a6f-4702-b7e6-a4b85ba0498e12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-834ELIMITE (PERMETHRIN) CREAM [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20240125_443c0446-ccba-4f52-83ed-4c3163f35807.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207485Elimite 5 % Topical CreamPSN443c0446-ccba-4f52-83ed-4c3163f358071
106387permethrin 5 % Topical CreamPSN443c0446-ccba-4f52-83ed-4c3163f358071
207485permethrin 50 MG/ML Topical Cream [Elimite]SBD443c0446-ccba-4f52-83ed-4c3163f358071
106387permethrin 50 MG/ML Topical CreamSCD443c0446-ccba-4f52-83ed-4c3163f358071
207485Elimite 5 % Topical CreamSY443c0446-ccba-4f52-83ed-4c3163f358071
207485Elimite 50 MG/1GM Topical CreamSY443c0446-ccba-4f52-83ed-4c3163f358071
106387permethrin 5 % Topical CreamSY443c0446-ccba-4f52-83ed-4c3163f358071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-834-60596510834601 TUBE in 1 CARTON (59651-834-60) / 60 g in 1 TUBE1 tube2024-01-22NoNoHistorical